NorthWise Recruitment™

Job Description

Our client is the global market leader in validated electronic patient diaries and multi-channel data capture for clinical trials. 

Summary:

The pre-sales support role is a senior level pre-sales, business process consultant position. This position is focused on supporting the sales team and the individuals who are responsible for selling the company’s products and services to FDA regulated Clinical Operations.

The Pre-sales support person will be familiar with the company sales process and working with all levels of individuals within the target prospect/ customer enterprise. The pre-sales position requires the individual to be comfortable working with multiple sales individuals to assist with activities involved in the sales cycle (proposals, demos, RFP responses, business process analysis, company software developmental diaries etc.) and to help account executives engaged in sales campaigns to close high six and seven figure sales opportunities.

The Role:

• Work hand in hand with account executives, to assist with sales activities in the development of clinical operation patient data collection solutions to successfully produce and close software and service sales.
• The specific responsibilities include but are not limited to : Analyzing complex clinical business and system processes, compiling return-on-investment analysis, assisting with project planning, demonstrating the software, and assisting the account executives in developing the overall value proposition as it relates to company software and services, proposing and responding to RFPs/RFIs, customer and new hire product training as may be required from time to time, planning and executing patient focus group events as maybe required with a project team, diary/questionnaire design/protocol development in the pre-sale activity required to close a project.
• Act as a Clinical Patient Data collection subject matter expert in the FDA regulated industries process by utilizing current expertise, staying current with new federal regulations, best practices and processes, and by sharing this knowledge with the sales team and prospect/customer accounts.
• Establish and maintain ongoing relationships with key account contacts to insure high degrees of customer satisfaction throughout the sales cycle and to leverage continued account growth.
• Assist CRF with developing prospect/client solution requirements, Business case justifications and ROI analysis to support the sale of the company Software Applications and implementation services.
• Assist the Sales individuals with the development of the technical implementation aspects for the company software applications

Experience/Qualifications required

• Ability to support and conduct presales activities in general and in the vertical (Pharmaceutical, Biotechnology, & Medical Device industries) company applications with a focus on regulated Clinical Trial Operations.
• 5-10 years of related experience in the Pharmaceutical industry –  Enterprise Wide Software Implementations..
• Major account consulting, management or presales experience in multi-division, multi-site pharmaceutical and Biotech clients.  Comfortable consulting at all levels within the organization up to the C level to learn and understand current business processes & practices, system & infrastructure plans and major corporate initiatives. Ability to search out and nurture relationships with key account contacts.
• Subject matter expert/expertise in areas such as; GCPs for the FDA regulated industries, Computer Systems Validation, SDLC, 21 CFR Part 11 e -records and e-signatures systems and controls, Software Implementation services and GACP methodologies in engagements ranging from Discovery through systems validation (i.e. IQ, OQ & PQ services.), and experience in pharmaceutical clinical trial operations.
• Must possess familiarity with EDC, CTMS, CTDM, Clinical Data analysis and reporting etc systems installation experience at Tier 1 and Tier 2 US and European Pharmaceutical manufacturers. Need to be subject matter familiar, pharmaceutical business professional, with extensive clinical trial data collection, large-scale project  expertise.
• Proficient knowledge of MS Office Applications (MS Office 98 and higher), the Internet, Microsoft .Net, XML solutions and related technologies. Must be able to install and demonstrate the product suite.
• Accustomed to frequent travel 25-30%, primarily local but some national and international as required
• Ability to give and assist with sales presentations discussing the business value of the Product Suite
• Experience in fast paced independent work environment – self starter
• Outstanding work ethic and the discipline to work hard
• Strong interpersonal, oral and written communication skills.
• Knowledge of and working familiarity of sales process methodologies to support a structured, activity based selling process, i.e., Holden Power Based Selling, Value Based Selling, Miller Hieman, etc.

• Bachelors degree required

Job Description

Our client is a recognised leader in the ePRO market. Founded in 2000 with corporate headquarters in Brussels, Belgium and Boston MA, a team of highly experienced professionals combine their expertise in clinical trials with cutting edge technologies to produce the most innovative product line in the ePRO market today.

This position is home based with regular meetings in Brussels office.

Summary:

The Sales Director, Europe is responsible for increasing the presence of the company’s solutions in the assigned market.  This is done through qualifying opportunities, strategically penetrating new accounts and managing existing client relationships

The Role:

• Meet or exceed sales quotas as defined by supervisors.
• Develop assigned territories by contacting targeted client base.
• Qualify and track opportunities using the company sales methodology and the CRM system.
• Identify sales opportunities, present solutions, answer RFPs and RFIs, submit   Proposals, secure contract, and coordinate transfer to project management.
• Work with Executive Vice President, Sales and Marketing and CEO on trade shows and marketing/sales strategy specific to their given territory.
• Develop an expansion plan with the Vice President, Sales and Marketing to grow territory.
• Organise and coordinate sales presentations for sponsor/client meetings and conduct proper follow-up.
• Demo company products to prospects in business and tradeshow settings.
•  Other duties may be assigned.

Experience/Qualifications required

• Thorough understanding of functionality of all company solutions.
• Understanding of the clinical trial process and the use of electronic systems within this process.
• Experienced in Microsoft Office Applications.
• Five plus years of business-to-business sales experience.
• Knowledge of pharmaceutical and clinical trials industry.
• Strong presentation and public speaking skills.
• Ability to represent the company to clients in a positive and professional manner.
• Strong negotiation and communication skills.
• Excellent writing skills.
• Strong analytical thinking. 
• Ability to interact with all levels of client personnel.
• Ability to work independently, with minimal supervision.

TRAVEL

As required to achieve the goals for the assignment

Qualifications:

• Four year degree or equivalent combination of education and experience.

Job Description

Location:               Raleigh, North Carolina

Type:                     Full time, permanent

Salary:                       tbc

Our client is a leading clinical data solutions provider specializing in data collection, data management and biometric solutions for the clinical trial community.

 Summary:

 Reporting to the Commercial Director / COO, the Data Solutions Consultant is responsible for finding and developing business from new customers.  Working as part of a supportive and dynamic sales team which includes operational staff, you will be required to manage the complete sales process from lead generation to final account management.  You will be offering of a range of clinical data solutions (services and technology). Your skills and experience will be required in matching these capabilities with a customers needs.

 With a professional approach to all aspects of the role, you will be expected to set-up, manage and conduct meetings with customers, attend conferences and exhibitions, and provide input to, and/or generate professional proposals. You should expect to travel regularly (approximately 4 times per month).

 This is not a ‘standard sales pitch’ role and requires full understanding of the challenges each potential customer faces within clinical trials. 

 
The Role:

 Meeting a sales target

Building and expanding the company’s presence within specific market sectors and      for pre-defined accounts

Developing long-term partnerships

Making initial contact with leads with a view to meeting with them

Extensive travel is expected

Arranging and managing meetings

Writing proposals

Preparing for and attending bid defense meetings

Presenting solutions to potential customers both by phone, at meetings and at  exhibitions

Managing key accounts with a view to gaining repeat business

Maintaining up to date and accurate records in the company CRM system

Preparation of weekly sales objectives

Contributing to weekly sales meetings

Experience/Qualifications required

Excellent knowledge of the healthcare industry and clinical trial process.  An    operational background is preferred.

Proven team oriented selling skills required and a general understanding and     working knowledge of technology.

Excellent communication skills, both written and oral

Excellent negotiation skills

Flexibility

Ability to apply an ‘intelligent’ approach to the sales process

Ability to manage a complex sales process including operational input

Good understanding of relevant regulations for both clinical trials and technology

Job Description

his is a great opportunity for an ambitious, target driven self-starter to join the UK's largest Phase I/II CRO, uniquely based within excellent facilities at the Mayday in Croydon and St George's in Tooting.

 Ideal candidates will have a minimum of 12 months sales experience; you will not need to have experience within the pharma industry as training will be provided to the right person.

 You will have outstanding communication skills and a proven track record of success.

 You will be able to demonstrate an understanding of the key principles of account management and the ability to develop relationships with key customers

Experience/Qualifications required

Sorry, full job requirements are not currently available for this job

Job Description

Our client is the UK's largest Phase I and II Contract Research Organisation and based within 2 University Teaching Hospitals. This gives access to world class consultants across an exceptional range of therapeutic areas and patient populations. By operating within acute NHS Trust surroundings, trials are conducted to the highest possible safety standards.

Clinical trials are run with healthy volunteers and small patient populations, with a reputation for high quality and innovative studies, from the design of the study through to the final report which ensures delivering innovative world class service to clients, and cutting edge technology and facilities are a testimony to this.

Summary:

Reporting

To the Head of Business Development

Responsibilities - Corporate Marketing

• To develop and deliver the annual corporate marketing plan
• To liaise with the Managing Director/Head of Business Development to devise effective sales and marketing strategies
• To generate leads for the business development team
• To manage the budget and provide regular ROI reports to Managing Director/Head of Business Development
• To develop and maintain all relevant marketing collateral
• To select and manage agencies

Responsibilities – Volunteer Recruitment Marketing

• To develop and deliver cost effective marketing solutions to Volunteer Recruitment requirements
• To liaise with Volunteer Recruitment to devise marketing recruitment strategies
• To manage the Volunteer Recruitment Marketing Budget and provide regular ROI reports to the Medical Director/Head of Business Development
• To develop and maintain all relevant marketing collateral
• To select and manage agencies

Experience/Qualifications required

Job Description

Our client is the global market leader in validated electronic patient diaries and multi-channel data capture for clinical trials. 

Summary:

The regional Director of Business Development is a senior level, “hunter” direct sales, customer relationship and territory management position focused on selling the company eDiary Solution and related implementation support services to the Life Science, regulated industries (pharmaceutical, Biotechnology and Medical Device). 

The Role: 

• Call on CEO, Exec VP President of R/D operations, Clinical Operations VP, Study Directors and Clinical Therapeutic area VPs to work with accounts to develop major enterprise partnerships sales.
• Contact and develop new prospects via email, telephone, and direct mail at all levels but particularly at the senior management level in named territory accounts regarding interest in the company’s TrialMax suite of software and support services.
• Analyse accounts and develop account penetration plan to increase future business growth of those clients currently using company products and services.
• Maintain established account relationships for continued growth.
• The Regional Business Development Director will be directly responsible for assisting the account penetration effort by direct mail, telephone and e-mail communication media to selected company, coordinating sales meetings with company resources, completing sales proposals and assisting as the Lead Team Leader of the account relationship. 
• Work with named accounts to successfully produce leads and close sales. 
• Work as a team member and assist market penetration effort with direct mail, telephone and e-mail communication to selected companies
• Major account development at large multi-division, multi-site pharmaceutical,   medical device, biotech and contract manufacturers

The Offering:

• The TrialMax solution sets a new standard in the industry for automating data capture and improving the quality of data received from subjects involved in clinical trials. TrialMax allows regulated manufacturers to quickly and incrementally roll out comprehensive and fully compliant ePRO diary solutions while leveraging their intranet, EDC and CTDM systems investments.
• TrialMax Software applications include Trial Manager, eQuery, Trial Collector, Trial Studio, Trial integrator, etc.
• A technology services company with a revenue plan to go to 23MM euros- in 2008.
• In business for 7 years with more than 130 projects done.  Reference accounts not an issue.
• Average sale value is 200k-300K GBP including services. Minimum sale value 100k GBP services only. High sale value $600 GBP in services and software licenses per project.
• Significant defined value proposition over competition. References in 16 of top 20 global pharma companies

Experience/Qualifications required

• Knowledge of Implementation services and methodologies in engagements ranging from Clinical Trial Protocol development thru concept Diary development and proposal submission as well as systems validation (i.e. Installation qualification (IQ), operational qualification (OQ) & performance qualification (PQ) services.)
• Accustomed to frequent travel, domestic and some international as required.
• Ability to give sales presentations and brief, high level demonstrations with company products.
• Experience in fast paced environment – self starter. Person must be highly accountable for weekly sales activities. This is a virtual office position
• Outstanding work ethic and the discipline to work hard without supervision. This is not a 9-5 position.
• Knowledge and track record of telephone surveying of company contacts at all levels for prospect identification development. This is a significant key skill for the position.
• Ability to analyze process Clinical Operations data collection and reporting process operation bottlenecks, develop business case for investment, prepare the proposal and close deal. In other words- define and execute a complex consultative selling process to address manual, paper based processes in the clinical operations area.
• Strong interpersonal, oral and written communication skills.
• Proficient knowledge of MS Office Applications (MS Office and higher), regulatory agencies (FDA, HMA, EMEA, etc) policies and practices for clinical operations Patient data collection and reporting, Computer Systems Validation, Electronic Records Electronic Signature (ERES), Pharmaceutical Industry clinical trial operations.
• Proven track record of achieving annual quota objectives at least of at least $2.5mm euros in services and license fee sales.
• Knowledge of and working familiarity of sales process, i.e., Value Based Selling, Holden Power Base Selling, Miller Hieman LAMP, Sandler,  etc.
• Familiarity with total enterprise involvement selling and comfort in selling at all levels of the enterprise. Use company management in tiered approach in reaching the contract signor, or key decision maker.
• Must be knowledgeable of consultative selling process including business process analysis and cost benefit solutions sales justification.
• Candidates must be able to understand and prosper in 6-8 month sales cycles.
• Must be driven, tenacious, committed, professional, creative and “hate to lose” competitive individual.
• Helpful Application software knowledge: ePRO, IVRS, IWRS, EDiary, EDC, CTMS, CTDM.

• Bachelor degree a must. MBA a nice to have but not at the expense of anything else, especially clinical operations knowledge and technology solution selling experience.

Job Description

Our client is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of state-of-the-art digital imaging technology for general radiography and mammography applications. Core business units are focused on osteoporosis assessment, mammography and breast biopsy, direct-to-digital x-ray for general radiography applications and mini C-arm imaging for orthopedic applications.

The Role:

• Manage the business relationships with dealer network including:
• Represent the company to local customer base including:
• Maintain relationships with luminary accounts.
• Monitor research partners.
• Provide sales support in key sales situations.
• Attend trade shows and educational events.

Represent the interests of the region in corporate interactions.

• Provide marketing input.
• Monitor competitive activities.
• Assist technical support staff with dealers and customers.
• Execute regions strategic plans.
• Coordinate problem accounts.

Conduct duties of sales management including:

• Obtaining annual sales budgets.
• Managing product mix and attention.
• Providing regular forecasts and BOD reports.
• Controlling regional expenses.
• Establishing budgets.
• Maintaining regular field travel with dealers (at least 50%)

Experience/Qualifications required

• 5+ years at management level for similar territory.
• Experience selling through dealer network.
• Experience in imaging modalities (especially mammo or digital)
• Ability to speak English and French
• Only candidates with the correct work permit/work visas will be considered.

Job Description

Our client is a leading global contract research organisation (CRO) providing clinical research and development services to the pharmaceutical and biotechnology industries, with operations across 39 locations world wide including the Americas, Europe, Asia Pacific and Africa, and currently employ over 2,700 people. Our client has established a first class reputation for exceptional quality, integrity and customer service.

Please Note: Only candidates with a valid permit will be considered for this position.

*

Italy                2.2 FTE

Sweden          0.5 FTE

Slovenia         0.5 FTE

Serbia             1.6 FTE

Prague           3.5 FTE

Slovakia         1.0 FTE

Netherlands  4.0 FTE

Romania        2.4 FTE

Summary:

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with company SOPs/WPs, applicable regulations and the principles of ICH -GCP

The Role:

• Familiarity with company SOPs/WPs, ICH-GCP and appropriate regulations.

• Familiarity with company Systems
• Familiarity with principles of investigator recruitment.
• Co-ordinate all the necessary activities required to set up and monitor a study, including the following:
• Identify investigators.
• Help, when requested, in preparation of regulatory submissions.
• Design patient information sheets and consent forms.
• Coordinate documents translation, verification and back translations where required.
• Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
• Pre-study and initiation visits.
• Conduct regular monitoring visits in accordance with the site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate
• Maintain all files and documentation pertaining to studies.
• Motivate investigators in order to achieve recruitment targets.
• Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Keep the project manager regularly informed.
• Process case record forms to the required quality standards and timelines.
• Deal with Sponsor generated queries in a timely manner.
• Ensure the satisfactory close-out of investigator sites.
• Ensure correct archiving of files on completion of a study.
• Co-operate with sponsor and/or company QA personnel in the conduct of QA audits.
• Participate in feasibility studies for new proposals, as required
• Maintain patient and sponsor confidentiality.
• To be cost effective
• To participate in mentoring of new staff up to Clinical Research Associate level as appropriate.
• Assist with marketing the company if and when appropriate.

Experience/Qualifications required

• Ability and willingness to travel at least 50% of the time (international and domestic: fly and drive).
• Ability to review and evaluate clinical data.
• Computer literacy desirable.
• Foreign language skills desirable.
• Current full driving licence essential.
• Good oral and written communication skills.

Job Description

Our client is a leading global contract research organisation (CRO) providing clinical research and development services to the pharmaceutical and biotechnology industries, with operations across 39 locations world wide including the Americas, Europe, Asia Pacific and Africa, and currently employ over 2,700 people. Our client has established a first class reputation for exceptional quality, integrity and customer service.

PLEASE NOTE: Only candidates with a valid work permit will be considered for this position.

*Locations/Salary:

Germany, Langen, Starting salary 39,000 Euros

Netherlands, Schiphol, starting salary 33,000 Euros

Belgium (based in Netherlands), starting salary 33,000 Euros

France, Paris, starting salary 30,000 Euros

Italy, Milan, starting salary 26,000 Euros

Israel, Lod, starting salary 130,000 ILS

Spain, Barcelona, starting salary 25,000 Euros

Portugal, starting salary 25,000 Euros

Sweden, Solna starting salary 360,000 SEK

Croatia, starting salary 27,500 Euros

Serbia, starting salary 27,500 Euros

Slovenia, starting salary 27,500 Euros

Latvia, Riga, starting salary 9,000 LVL

Ukraine, Kiev, starting salary 20,000 Euros

UK, Marlow/Eastleigh, field based, starting sal £22,500

Lithuania, Vilnius, starting salary 14,493 Euros

Russia, Moscow, starting salary 19,500 Euros

Romania, Bucharest, 27,500 Euros

Poland, Warsaw, starting salary 24,000 Euros

Summary:

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with company SOPs/WPs, applicable regulations and the principles of ICH -GCP

The Role:

Familiarity with company SOPs/WPs, ICH-GCP and appropriate regulations.

• Familiarity with company Systems
• Familiarity with principles of investigator recruitment.
• Co-ordinate all the necessary activities required to set up and monitor a study, Including the following:
• Identify investigators.
• Help, when requested, in preparation of regulatory submissions.
• Design patient information sheets and consent forms.
• Coordinate documents translation, verification and back translations where required.
• Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
• Pre-study and initiation visits.
• Conduct regular monitoring visits in accordance with the site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate
• Maintain all files and documentation pertaining to studies.
• Motivate investigators in order to achieve recruitment targets.
• Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Keep the project manager regularly informed.
• Process case record forms to the required quality standards and timelines.
• Deal with Sponsor generated queries in a timely manner.
• Ensure the satisfactory close-out of investigator sites.
• Ensure correct archiving of files on completion of a study.
• Co-operate with sponsor and/or company QA personnel in the conduct of QA audits.
• Participate in feasibility studies for new proposals, as required
• Maintain patient and sponsor confidentiality.
• To be cost effective
• To participate in mentoring of new staff up to Clinical Research Associate level as appropriate.
• Assist with marketing the company if and when appropriate.

Experience/Qualifications required

• Medical/science background and relevant experience.
• Ability and willingness to travel at least 50% of the time (international and domestic: fly and drive).
• Ability to review and evaluate clinical data.
• Computer literacy desirable.
• Foreign language skills desirable.
• Current full driving licence essential.
• Good oral and written communication skills

Job Description

Our client is a leading global contract research organisation (CRO) providing clinical research and development services to the pharmaceutical and biotechnology industries, with operations across 39 locations world wide including the Americas, Europe, Asia Pacific and Africa, and currently employ over 2,700 people. Our client has established a first class reputation for exceptional quality, integrity and customer service.

PLEASE NOTE: Only candidates with a valid work permit will be considered for this position.

*Locations/Salary: 

Germany, Langen, Starting salary 39,000 Euros

Netherlands, Schiphol, starting salary 33,000 Euros

Belgium (based in Netherlands), starting salary 33,000 Euros

France, Paris, starting salary 30,000 Euros

Italy, Milan, starting salary 26,000 Euros

Israel, Lod, starting salary 130,000 ILS

Spain, Barcelona, starting salary 25,000 Euros

Portugal, starting salary 25,000 Euros

Sweden, Solna starting salary 360,000 SEK

Croatia, starting salary 27,500 Euros

Serbia, starting salary 27,500 Euros

Slovenia, starting salary 27,500 Euros

Latvia, Riga, starting salary 9,000 LVL

Ukraine, Kiev, starting salary 20,000 Euros

UK, Marlow/Eastleigh, field based, starting sal £22,500

Lithuania, Vilnius, starting salary 14,493 Euros

Russia, Moscow, starting salary 19,500 Euros

Romania, Bucharest, 27,500 Euros

Poland, Warsaw, starting salary 24,000 Euros

Summary:

• Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, company SOPs/WPs, applicable regulations and the principles of ICH-GCP
• Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of company systems and procedures as appropriate.
• Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
• Provide a benchmark for acting according to company values and act as a positive promoter for the company
• • The Role:

• Knowledgeable of company SOPs/WPs, ICH-GCP and appropriate regulations.

• Knowledgeable of company systems
• Recruitment of investigators.
• Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
• Identify investigators.
• Help, when requested, in preparation of Regulatory submissions.
• Design patient information sheets and consent forms.
• Co-ordinate documents translation, verification and back translations where required.
• Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
• Placement and initiation visits.
• Conduct regular monitoring visits in accordance with the site monitoring SOP/Sponsor site monitoring SOP, as appropriate
• Maintain all files and documentation pertaining to studies.
• Motivate investigators in order to achieve recruitment targets.
• Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Keep the project manager regularly informed.
• Process case record forms to the required quality standards and timelines.
• Deal with Sponsor generated queries in a timely manner.
• Ensure the satisfactory close-out of investigator sites.
• Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
• Ensure correct archiving of files on completion of a study.
• Maintain patient and sponsor confidentiality.
• Assume additional responsibilities as directed by Associate Clinical Project Manager/Clinical Project Manager (CPM).
• Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a CPM/Associate Clinical Project Manager.
• Co-ordinate and/or participate in feasibility studies for new proposals, as required.
• Be cost effective.
• Participate in mentoring and training new staff.
• Assist with marketing the company if and when appropriate.

Experience/Qualifications required

• Ability and willingness to travel at least 50% of the time (international and domestic: fly and drive).
• Ability to review and evaluate clinical data.
• Computer literacy desirable.
• Foreign language skills desirable.
• Current full driving licence essential.
• Good oral and written communication skills.

Job Description

Our client is a leading global contract research organisation (CRO) providing clinical research and development services to the pharmaceutical and biotechnology industries, with operations across 39 locations world wide including the Americas, Europe, Asia Pacific and Africa, and currently employ over 2,700 people. Our client has established a first class reputation for exceptional quality, integrity and customer service.

PLEASE NOTE: Only candidates with a valid work permit will be considered for this position.

*Locations/Salary: 

Germany, Langen, Starting salary 39,000 Euros

Netherlands, Schiphol, starting salary 33,000 Euros

Belgium (based in Netherlands), starting salary 33,000 Euros

France, Paris, starting salary 30,000 Euros

Italy, Milan, starting salary 26,000 Euros

Israel, Lod, starting salary 130,000 ILS

Spain, Barcelona, starting salary 25,000 Euros

Portugal, starting salary 25,000 Euros

Sweden, Solna starting salary 360,000 SEK

Croatia, starting salary 27,500 Euros

Serbia, starting salary 27,500 Euros

Slovenia, starting salary 27,500 Euros

Latvia, Riga, starting salary 9,000 LVL

Ukraine, Kiev, starting salary 20,000 Euros

UK, Marlow/Eastleigh, field based, starting sal £22,500

Lithuania, Vilnius, starting salary 14,493 Euros

Russia, Moscow, starting salary 19,500 Euros

Romania, Bucharest, 27,500 Euros

Poland, Warsaw, starting salary 24,000 Euros

Summary:

• Identify, select, initiate and close-out appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with company SOPs/WPs applicable regulations and the principles of ICH-GCP.
• Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
• The Role:
• Knowledge of company SOPs/WPs, ICH-GCP and appropriate regulations.
• Knowledge of company systems
• Recruitment of investigators.
• Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:
• Identify investigators.
• Help when requested, in preparation of regulatory submissions.
• Design of patient information sheets and consent forms.
• Coordinate documents translation, verification and back translations where required.
• Ensure timely submission of protocol/consent/Safety reports documents for ethics/IRB approval.
• Pre-study and initiation visits.
• Conduct regular monitoring visits in accordance with the company site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate
• Maintain all files and documentation pertaining to studies.
• Motivate investigators in order to achieve recruitment targets.
• Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Keep the project manager regularly informed.
• Process case record forms to the required quality standards and timelines.
• Deal with Sponsor generated queries in a timely manner.
• Participate in feasibility studies for new proposals, as required
• Ensure the satisfactory close-out of investigator sites.
• Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Clinical Project Manager (CPM), if appropriate.
• Ensure correct archiving of files on completion of a study.
• Maintain patient and sponsor confidentiality.
• Assume additional responsibilities as directed by Associate Clinical Project Manager/CPM/Clinical Project Director.
• To be cost effective.
• Participate in mentoring new staff.
• Assist with marketing the company, if and when appropriate.

Experience/Qualifications required

• Ability and willingness to travel at least 50% of the time (international and domestic: fly and drive).
• Ability to review and evaluate clinical data.
• Computer literacy desirable.
• Foreign language skills desirable.
• Current full driving licence essential.
• Good oral and written communication skills.

Job Description

Our client is one of the world’s foremost biotechnology companies dedicated to making a major positive impact on the lives of people with serious diseases. With many established products and services helping patients in nearly 90 countries, our client is a leader in the effort to develop and apply the most advanced technologies in the life sciences.

Summary:

The function of Clinical Pharmacist is part of the Clinical Pharmacy Services (CPRS) department (9 staff). This department is a unit of BMRA EU Operations (approx. 25 staff in-house and approx. 35 on-site monitors). It is responsible for the labeling, distribution and shipment of clinical trial material for clinical trials in conformity with ICH/GCP and GMP. Department staff assists the project managers and the clinical research sites staff with pharmaceutical expertise. The department Operations provides staff and facilities to support processes in the BMRA Division. Approximately 150 people work in this Division.

The Role:

Ascertain that all clinical material and medical devices for clinical trials in Europe are available at the clinical trial site on time in the right country-specific labeling and packaging with the correct technical information, as requested by ICH/GCP and GMP and national regulations.

Provide pharmaceutical assistance to the internal (the project team) and external (hospital pharmacist) parties and evaluate the quality of requested handling of research products at the clinical site.

General preparatory activities

• Review of clinical trial protocol and provide input as to product-specific characteristics and procedures and choice of comparator product
• Participate in project team meetings
• Collect country-specific information such as import licenses for clinical trial materials, requested label texts and translations, in collaboration with the regulatory department
• Check availability of clinical trial material and medical devices for running and planned clinical trials in consultation with CPRS-US, CPRS-UK or third parties and place orders if necessary
• Inform packaging and distribution offices at CPRS-US and CPRS-UK about planned timelines and by doing so, start up timely label and packaging development and the process of labeling and packaging
• Purchase comparator medication for clinical trials
• Request randomization lists and coding envelops from the Biostatistics Department

Activities linked to the delivery of clinical trial material to clinical sites:

• Request import licenses for clinical trial material
• Plan and manage correct delivery of clinical trial material for long-term clinical studies
• Review shipment orders as prepared by the pharmacy or CPRS Technician

Activities related to providing pharmaceutical technical assistance:

• maintain contracts with hospital pharmacist, CRAs and clinical project managers
• Write pharmacy manuals on the medication for the hospital pharmacist
• Carry out pre-study visits to evaluate the technical quality of the clinical site pharmacy and carry out initiation visits at the formal start of the clinical trial
• Act as source of technical information for the hospital pharmacist with regards to product-specific matters, such as product shelf-life, in collaboration with CPRS-US and PCRS-UK
• Play an active role in product complaint handling

• Close collaboration with CPRS-US in pharmaceutical matters. Meet with and inform clinical project managers and CRAs, inform and advise hospital pharmacists about technical aspects, care of, supply and delivery of clinical trial material.
• Meet with, inform regulatory staff about import licenses, package inserts, labels, and with CPRS-US and CPRS-UK about label development, package design and planned packaging activities, orders and shipments to various clinical trial material.

N.B.  Due to the international nature of the company, all communications are in English.

• Often working with tight timelines
• Some travel abroad (20-30 days a year)

Experience/Qualifications required

• Use of a keyboard (PC) and use of common MS Office applications
• Analytical approach
• Accuracy and an eye for detail working with clinical material and data
• Excellent English, both written and oral
•  Qualified pharmacist

Job Description

Our client is one of the world's largest and most comprehensive drug development services companies and has the people, global resources and problem-solving culture to respond to pharmaceutical and biotechnology clients' toughest drug development challenges.

Summary:

• The Senior Clinical Research Associate is responsible for:
• Assuring the implementation of project plans as assigned
• Functioning as leader for projects of limited scope as assigned.
• Assuming line management responsibilities as assigned.
• Site administration and site monitoring responsibility for clinical studies according to appropriate Standard Operating Procedures, ICH Guidelines and GCP
• Site management responsibility for clinical studies according to appropriate Standard Operating Procedures, ICH Guidelines and GCP
• Acting in the project role of as Local Project Coordinator or Lead CRA as assigned.

The Role:

• Manage small projects under direction of a Project Manager/Director as assigned.
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator Meetings.
• Report, write narratives and follow-up on serious adverse experiences.
• Participate in the development of protocols and Case Report Forms as assigned.
• Participate in writing clinical trial reports as assigned.
• Interact with internal work groups to evaluate needs, resources and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• Responsible for all aspects of registry management as prescribed in the project plans.
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.

General On-Site Monitoring Responsibilities

• Ensure the study staff conducting the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
• Ensure the resources of the Sponsor are spent wisely by performing the required monitoring tasks in an efficient manner, according to appropriate SOPs and established guidelines, including managing travel expenses in an economical fashion according to appropriate travel policy.
• Prepare accurate and timely trip reports.
• Undertake feasibility work when requested.
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
• Negotiate study budgets with potential investigators and assist the legal department with statements of agreements as assigned.
• Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on appropriate data management systems as assigned by management.
• Assist with training, mentoring and development of new employees, e.g. co-monitoring
• Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local contact as assigned.
• Perform other duties as assigned by management.

Travel Requirements:

• Available for travel up to 50%-80% of the time including overnight stays as necessary consistent with project needs and office location
• If designated a project Lead CRA, available travel adjusted to reflect up to 10-25% of the time including overnight stays as necessary consistent with project needs.

Experience/Qualifications required

• Language Skills Required:   Fluent in English and French
• Four or more years of relevant clinical research experience in pharmaceutical or CRO industries
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process

Preferred:

• Thorough knowledge of appropriate S.O.P.s regarding site monitoring
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Excellent site monitoring skills
• Excellent study site management skills
• Excellent registry administration skills
• Ability to work with minimal supervision
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Excellent verbal and written communication skills
• Ability to train and supervise junior staff
• Ability to resolve project-related problems and prioritizes workload for self and team.
• Ability to work within a project team
• Works efficiently and effectively in a matrix environment
• One or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management

Qualifications:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.

Job Description

Our client is a specialised Contract Research Organisation (CRO) with a long-standing history of therapeutic specialty and technological innovation.   They are the foremost global CRO specialising in CNS, Oncology and data services.  

Summary:

As a CRA you would be responsible for monitoring all types of clinical trials; assures adherence Good Clinical Practices, investigator integrity and compliance with all study procedures.

The Role:

Primary responsibility is site management and performance (including required documentation) according to ICH guidelines (country specific guidelines and government regulations), as well as FDA regulations (state and local laws), GCPs, and SOPs. 

Site management activities include all in house and on-site monitoring for all visit types after observation and supervision of these visits by an experienced monitor and assessment by manager.

Site Selection:

• Assist with the identification and contacting of potential investigators;
• Ensure adequacy of clinical research staff/facilities with regard to company Standard Operating Procedures (SOP) and global regulatory requirements and identifies issues and problems for resolution by lead Clinical Research Associate (LCRA).

Study Initiation:

• Conduct site initiation visits. 
• Ensure completion of regulatory documents; reviews investigator responsibilities;
• Assist with coordination of shipment of study-related material;
• Attend investigator’s meetings and as appropriate help with the preparation of the materials to be presented

• Assess and manage overall investigational site performance including assisting with site issues such as enrollment.
• Ensure investigators’ adherence to protocol and initiates corrective action to resolve issues (with input from Lead CRA or manager).
• Ensure regulatory documents are available and current.
• Provide frequent updates to the Trial Master File during interim monitoring period
• Review Case Report Forms (CRF) for completeness and accuracy and ensures corrections are appropriately made.
• Perform source document verification.
• Review Adverse Event incidence, both serious and non-serious, and follows reporting procedure to the company/sponsor.
• Review Data Clarification Form (DCF) resolution.
• Review clinical listings as appropriate.
• Ensure Investigational Product (IP) accountability.
• Review informed consent process and documentation
• Assure site compliance with Institutional Review Board or Independent Ethics Committee (IRB/IEC) reporting obligations.
• Prepare visit reports within study timelines utilizing acceptable business writing skills
• Document all study issues and recommending corrective action as necessary.
• Maintain regular telephone contact with site and assist with study help-lines as needed.
• Maintain study specific tracking files and databases.
• Maintain written correspondence with site.
• Track investigator payment status, if applicable.
• Communicate all issues and updates with study management including Project Manager and Lead CRA as appropriate.
• Perform in-house clinical CRF review, if applicable

Study Termination:

• Review and retrieve remaining CRFs
• Resolve all outstanding DCFs.
• Ensure regulatory documents are available and current.
• Ensure IP accountability and reconcile IP for return and/or disposal per sponsor guidelines.
• Review record retention requirements with Clinical Investigator.
• Review possibility of audits/inspections with Clinical Investigator.
• Secure and review investigator’s final report within the company or Sponsor SOPs or guidelines.  
• Completes core clinical training program and develops independent monitoring skills
• Responsible for writing basic clinical study documents (visit reports, correspondence, etc.) Performs administrative duties, including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions, etc.
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by reading related literature, attending training classes, attending professional meetings, etc.  
• Performs other work related duties as assigned.  

Experience/Qualifications required

• Preferably a minimum of one-year clinical research experience in CNS or Oncology and other related research experience. 
• Direct clinical research experience and knowledge of procedures related to clinical trials is necessary. 
• Requires thorough knowledge of ICH Guidelines, FDA regulations, (or other country specific guidelines), GCPs, and medical terminology. 
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. 
• Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Basic computer skills in Word, Excel and Email are necessary.  
• A willingness to travel up to 75% of time is essential.      

Qualifications:

• Requires a B.A. /B.S. in the science/health care field, nursing degree, or equivalent. 

Job Description

Our client is a specialised Contract Research Organisation (CRO) with a long-standing history of therapeutic specialty and technological innovation.   They are the foremost global CRO specialising in CNS, Oncology and data services.    

Summary:

As a CRA II you would be responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. May serve in Lead CRA role.

The Role:

• Maintains timely and effective communication among team members and site staff.
• Keeps project leadership apprised of team issues, seeking guidance as needed.
• Participates in Business Development client presentations and bid defenses as requested.
• Assures compliance with CFR, State regulations, ICH and GCP guidelines, company and sponsor SOPs.
• Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
• Participates in TMF and on-site audits as requested
• Assumes responsibility for site management and site staff performance including:
• Monitors all types of clinical trials.
• Participates in all types of site visits.
• Assures Principal Investigator (PI) integrity.
• Assures compliance with all protocol requirements.
• Assures effective patient identification and recruitment plan is in place.
• Assures timely reporting of AEs/ SAEs and Protocol Violations.
• Regularly perform Investigational Product (IP) accountability.
• Regularly review the status of contents of the site Regulatory Binder
• Performs source document verification (SDV) according to contractual requirements.
• Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
• Assures timely and accurate completion of Data Clarification Forms (DCFs).
• Performs clinical data listings reviews as needed
• Completes and submits visit trip reports according to SOP requirements and requiring minimal revisions.
• Maintains awareness of key study performance indicators for own sites, e.g. patient enrollment, SAEs.
• Updates study and patient status information and serves as (CTMS) resource for PM/LCRA.
• Tracks Investigator payments/ milestones, if requested.
• Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit
• Prepares for and attends investigator’s meetings as requested.
• Assists with the preparation of study start up materials and tools, as requested.
• Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.
• May assume Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training
• Performs other work related duties as assigned.
• Demonstrates basic understanding of SOPs, WI, FDA and local regulations as well as ICH guidelines.
• Demonstrates competent level knowledge of protocol and disease related terminology for study for which the individual is under consideration or assigned
• Applies knowledge of the Drug Development process appropriately to studies.
• Ability to handle most aspects of site selection, site initiation, site monitoring and close out visits with minimal supervision.
• Extensive travel may be required (more than 50%).  

Experience/Qualifications required

• Preferably proven knowledge clinical or research experience in CNS, Oncology and/ or Pediatrics or other related research experience. 
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. 
• Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

Qualifications:

• Requires a B.A. / B.S. in the science/health care field, nursing degree, or equivalent related experience. 

Job Description

 Our client is the UK's largest Phase I/II Contract research unit, uniquely based within excellent facilities at two hospital sites at the Mayday in Croydon and St George's in Tooting, conducting clinical trials for many of the major pharmaceutical companies, with healthy volunteers and patients to help develop new medicines.

This is a great opportunity for an enthusiastic NMC registered Nurse to join a team maintaining the highest level of efficiency, competence and safety during trials. Hard working and self driven you will work as part of a multi disciplinary team and will be fully involved, conducting trial specific procedures such as taking vital signs and ECG's, intravenous cannulation and electronic data collection.

 The working environment is energetic and proactive, with opportunities for career progression for the right person. Our client is offering a competitive salary, full training, and sponsorship towards relevant CPD.

 Based across both sites, you will work on a shift system which will include weekends and some nights, so flexibility over working hours is key.

Experience/Qualifications required

Fluency in English, both written and spoken, is essential.

Relevant industry experience or in A&E or ITU would be advantageous.

Job Description

Our client the UK's largest early phase Contract Research unit, uniquely based within excellent facilities at 2 teaching hospitals, St George's Hospital in south west London and the Mayday Hospital in Croydon.

Our client conducts medical research with healthy volunteers and patients to help develop new medicines. They are also the biggest provider in Europe of bridging studies which compare Japanese to Caucasian populations. To ensure the safety and cultural needs of their volunteers, they need you!

You will join the Clinical department, working alongside our Nurses and Physicians you will be helping conduct the trials, performing clinical tasks and ensuring volunteer safety.

Based across both sites, you will work on a shift system which will include weekends and some nights so you need to be flexible in your approach.

Experience/Qualifications required

It is essential for this role that you are a graduate, preferably with experience in Nursing or Pharmacy. You should have excellent Japanese and English language and written skills. Previous experience in clinical research is desirable.

Job Description

Our client is the UK's largest early Phase Contract Research Organisation (CRO) uniquely based within excellent facilities at 2 university hospital sites, Mayday Hospital in Croydon and St George's Hospital in Tooting.

 This is a great opportunity for an enthusiastic NMC registered Nurse to join a team maintaining the highest level of efficiency, competence and safety during trials. Hard working and self driven you will work as part of a multi disciplinary team and will be fully involved, conducting trial specific procedures such as taking vital signs and ECG's, intravenous cannulation and electronic data collection.

 Highly ethical, this is a young and dynamic company; the working environment is energetic and proactive, with opportunities for career progression for the right person. On offer is a competitive salary, full training, and sponsorship towards relevant CPD.

 Fluency in English, both written and spoken, is essential. Relevant industry experience or in A&E or ITU would be advantageous.

 Based across both sites, you will work on a shift system which will include weekends and some nights, so flexibility over working hours is key.

Experience/Qualifications required

Sorry, full job requirements are not currently available for this job

Job Description

Salary:    Negotiable depending on experience

 Our client is the UK's largest early Phase Contract Research Organisation (CRO) uniquely based within excellent facilities at 2 university hospital sites, Mayday Hospital in Croydon and St George's Hospital in Tooting.

This is an excellent opportunity for an experienced CRA to help supervise the Clinical Monitoring team and to take the lead role in monitoring studies to ensure excellence in quality and integrity of data, compliance with SOP's and regulatory requirements.

You should be a life science graduate with at least 3 years monitoring experience, ideally including supervision of staff so that you can help coordinate the workload and review training needs and work processes. Good communication skills are also essential as you will be liaising with Data Management and Pharma clients as well as colleagues across the business.

If you have 'a can do' attitude and are motivated by responsibility and opportunity then this role offers you the chance to apply your expertise and be rewarded for your hard work.

 Based across both sites, you will need to be flexible and well organised in your approach, have meticulous attention to detail and be committed to developing your career.

Experience/Qualifications required

Sorry, full job requirements are not currently available for this job

Job Description

Our client is a young, dynamic and growing international CRO with specialist experience in cardiology, oncology and long term partnerships, offering consulting and full operational clinical development services.

The Role:

Reporting directly to the Regional Director Operations, the successful candidates tasks will involve:-

• On site monitoring
• Supporting of Regulatory and Ethics committee submissions
• In-house monitoring
• Study tracking and review of data

Experience/Qualifications required

At least 1 year experience as a CRA/Monitor in a CRO or Pharma company

A good understanding of ICH/GCP requirements

Willingness to travel up to 50% of the working time

A proven ability to take initiative, organise, co-ordinate and follow up independently

• Excellent communication, organisational and interpersonal skills and ability for problem solving
• Fluent written and spoken English is mandatory; any additional language skills are desirable
• A proven ability to work efficiently in a team environment and under pressure
• Good knowledge of Microsoft Office applications

• A degree in life sciences (eg Biology, Pharmacy, Nursing, Medicine)

Job Description

Our client has one of the largest global footprints of any CRO. They are committed to establishing and maintaining the industry's strongest multi-national presence. Their monitors have the most extensive knowledge of local and regional customs and sites across a broad range of therapeutic areas.

Summary:

The Senior CRA will operate as the focus for communication with Clinical Research Associates (CRAs) and the Sponsor. Act as the lead contact of the project team with study site personnel and ensure that the clinical trial is conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice.

The Role:

Support the Project Manager with the day-to-day functional and organisational activities of clinical trial management.

• Liaise with CRAs and Sponsor to track study progress and milestones; regulate quality standards; resolve logistical and practical issues, and promote the team-working environment.
• Establish regular communication with CRAs and CROs, and assess the quality, timeliness and expenditure for the Clinical Trial.
• Provide functional assistance to project team members with administrative, logistical and practical issues, including collection, distribution and filing of relevant study documentation.
• Identify potential logistical / practical problems and propose solutions / contingency plans, with costings and time frames for resolution.
• Supervise generation of electronic tracking systems and paper logs, and the ongoing collection of data, for the production of status updates / progress reports, including patient recruitment and withdrawal, SAEs, CRF and data query transmission.
• Review study related documentation for compliance with SOPs and ICH-GCP Guidelines, particularly Regulatory / Ethics Committee review and approval, CVs, drug accountability, translations, SAE reports, etc.
• Alert Medical Adviser / Director and Project Manager immediately on receipt of SAE report from study site, prior to forwarding to the Sponsor (where necessary).
• Assist the Project Manager with generation of study specific forms for completion by CRAs and Investigators.
• Follow-up Sponsor’s requests for clarifications; supplementary information; distribution of newsletters and review approval of protocol amendments; financial disclosures (FDA form 1572), Clinical Investigator Brochure revisions; translations etc.
• Participate in contract negotiations with central laboratories, couriers and other external organisations, e.g. sub-contractors for printing, monitoring, data processing, external quality assurance, etc.
• Organise processes for interim and final payments to Investigators, including preliminary calculations, review and approval from project management, liaison with company accountant, logging trial expenditure, receipts, invoices and income.
• Process and track payments to the Ethics Committees, Regulatory Authorities, Investigators, laboratories and CRAs (sub-contracted / part-time), including timely notification of finance department.

Supervise Selection, Initiation, Monitoring and Closure at Investigator Sites according to project schedule. Ensure CRA team adheres to project guidelines for monitoring requirements.

• After identifying the minimum requirements for Investigator Site participation, initiate the process for assessing the feasibility of a proposed study.
• If required attend Investigator Selection and Initiation visits. Co-monitor sites in supervisory role and review local site and in-house study files, to ensure consistency in protocol interpretation, monitoring standards and compliance with monitoring  responsibilities.
• Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members.
• If required to monitor locally, conduct Site Monitoring visits in accordance with project Monitoring Guidelines, at the frequency specified in the Sponsor contract.
• During Monitoring Visits assess the study progress at the Investigator Site. Check the completion of study data and patient records; by performing Source Data Verification, Accountability for study drug and other trial materials; compliance with study procedures and GCP, and for safety monitoring.
• Review Site Visit Reports for accuracy, legibility and completeness before signing off and forwarding to Sponsor.

Supervise the Import, Delivery and Return of Trial Medication and other Trial Materials.

• Ensure Study Medications are appropriately stored for the duration of the trial.
• Monitor and record Drug Accountability throughout the study.
• At the end of the study, assist sites in returning Trial Medication(s) to the Sponsor, or with arrangements for the local destruction of remaining supplies.
• Ensure adequate supplies of trial materials (CRFs, study medications, laboratory kits, etc.) are available at trial sites throughout the period of the study.
• Liaise with local and/or central laboratories and courier companies, if appropriate, to organise import and distribution of laboratory kits, transportation of biological samples to the laboratory for analysis, and transmission of results to the site/CRA/Sponsor.
• Communicate on a regular basis with Sponsor and Trial Material suppliers e.g. printers, regarding the supply, importation and transportation of Trial Materials to participating countries.

Maintain regular and effective verbal and written communication with project Team members and where appropriate, the Sponsor.

• Provide the project team with comprehensive details of local activities relating to designated clinical trials.
• Where appropriate, obtain documented approval for or advice on issues which may impact on a clinical study e.g. expenditure; absence from office; resolution of problems; implementation of contingency plans; etc.
• Report any major problems or violations to the Project Manager, preferably during the site visit, or as soon as possible afterwards, with proposed resolutions and/or actions performed.
• Participate in teleconferences with the Sponsor, central laboratory, data management, etc. where applicable.
• Prepare and transmit updated patient status reports to the Project Manager, at specified intervals.

Develop a comprehensive knowledge of the study protocol and other relevant documentation.

• Sustain the company record of high productivity, quality, efficiency and co-operation, by working in accordance with corporate SOPs, ICH-GCP and FDA guidelines and contractual obligations, and within specified financial and temporal constraints.
• Attend Project CRA training meetings or teleconferences as required.

Supervise CRAs in obtaining key GCP documents prior to Site Initiation for appropriate filing and distribution. Maintain updated study Investigator Site and In-house Files for the duration of the study.

• In a timely manner identify and collect documentation for submission to Regulatory Authorities and Ethics Committees, including appropriate translations.
• Liaise with hospital management and legal advisors regarding the Investigator Contract, and if appropriate generate or amend such agreements according to local laws and regulations.
• Ensure Investigator Contract (and any additionally required site contracts, e.g. laboratory or radiologist contract) is signed in a timely manner and CVs of key site staff are obtained prior to Site Initiation.
• Supervise the preparation of study files, Investigator and Monitoring Guidelines. Routinely review filing systems for key study documentation.
• In collaboration with Clinical Trial Associates prepare and maintain local office In-house and Investigator Site Files, and securely store all other trial materials under appropriate conditions.
• File a hard copy of all trial documentation in the relevant Country or Site files as per company SOPs.
• Regularly review the status of key documentation in the Master / Country files, in compliance with SOPs and to facilitate satisfactory audit inspections.
• Produce and maintain computerised records of study progress; receipt/transfer of documentation and/or site visit schedules.

Maintain regular contact with Investigator and Site staff by means of letters, emails and telephone calls. Provide Sites with necessary study updates and documents. Monitor sites adherence to protocol and regulatory procedures, and provide ongoing support site support and training for study procedures.

• Deliver any protocol amendments and/or updated documentation e.g. Investigator’s Brochure, to the investigator, for review and approval (where necessary) by the EC.  Similarly, provide a copy to the Regulatory Authority for their reference/approval.
• Update the investigator on study progress via newsletters and provide details on interim analyses; etc.
• Advise the Investigator on completion and organisation of study forms and documentation in the Investigator Site File.
• Remind investigators of their obligation to report any serious and/or unexpected adverse events to the monitor within 24 hours, for subsequent transmission by the monitor to the sponsor and the company, and also to inform their EC in a timely manner.
• Arrange for delivery of safety reports (or CIOMS (Council for International Organisations of Medical Sciences) forms to all sites involved in the study for review by the investigators and their ECs.
• Support Project Manager in organising Investigator Meetings. Arrange agenda and speakers. Prepare or obtain presentation materials including manuals, acetate overheads, visual aids, drug packaging and labelling, laboratory kit(s), translations, etc.
• Assist the Project Manager and Investigator in designated preparations for and conduct of site audits.
• Forward completed CRFs and resolved data queries/clarifications by courier to the Sponsor, according to study guidelines
• Where appropriate, assist the project team with the investigator payment process.

Develop and maintain a working knowledge of current company SOPs and ICH-GCP & FDA requirements. Attend training courses and seminars as designated by senior management.

• Attend Clinical Research, CRO and / or GCP conferences, or other promotional / marketing events, to support personal and Business Development needs.
•  
• Prepare / update modules for training courses, advanced training seminars. Assist project management with study specific training activities provide expertise in protocol interpretation / CRF completion.

Experience/Qualifications required

• ·All requirement from CRA Grade III level
• ·Minimum experience of 1-2 years at CRA grade III level
• ·Good Presentation skills
• ·Co-ordination skills
• ·Experienced in conducting allocated tasks
• ·Maintain up-to-date knowledge of ICH-GCP, EU CT Directive and FDA guidelines
• ·Experience in grade IV duties

Job Description

Our client is a well-established UK based clinical research organisation (CRO), providing services and solutions to the medical device, pharmaceutical and healthcare industries. The company has been serving these industries for almost 10 years and has an excellent track record in service delivery and client satisfaction.

Summary:

This role involves the planning, implementation and monitoring of international, multi-centre, regulatory and post-marketing surveillance programs to the highest ethical, clinical and scientific standards.

Role:

• Liaison with Sponsor Company to assist in the successful planning and execution of projects.
• Obtain the necessary Essential Documents required for initiation of Clinical Trials including REC submissions, Competent Authority submissions and R&D submissions.
• Be responsible for the initiation and conduct of Clinical Trials at investigator sites.
• Be responsible for the monitoring of Clinical Trials at investigator sites.
• Ensure that all Clinical Research is conducted in compliance with Company policies, practices and procedures and all applicable regulatory requirements, where applicable.

Experience/Qualifications required

• Minimum 18 months monitoring experience in Clinical Trials with medicinal products or 12 months experience within the medical device arena.
• Degree in science or equivalent nursing qualification.

Job Description

Salary:  450 – 500.000 DKR (including 10% pension)

Our client is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs in the treatment of psychiatric and neurological disorders.

Summary:

The Senior Data Manager will:-

Manage all clinical data from study kick-off meeting to archiving in conjunction with clinical trials. This includes all aspects of study set-up, data validation, database quality control and release of a database for statistical analysis as well as documentation and archiving of performed tasks. This implies ongoing communication and collaboration with a wide variety of team members worldwide and adherence to current SOPs, Working Instructions and regulatory guidelines.

Take on project responsibility and to assist colleagues in CDM issues

The Role:

• To participate in study management team meetings and contribute to the discussions on behalf of CDO
• To review and comment on the protocol synopsis
• To give input to, review and comment on the protocol
• To coordinate the preparation of the CRF/eCRF and any amendments in cooperation with the CRF designer and be responsible for the CRF workshop
• To prepare the CRF Monitoring Guideline according to the CRF and the protocol (if applicable)
• To prepare the Data Clarification Conventions document
• To train the CRAs in CRF completion and monitoring before and during a trial regarding quality issues and logistical tasks, e.g. by participating in CRA Meetings
• To prepare the annotated CRF/eCRF
• To set-up the database and data entry application, if needed in cooperation with a database programmer
• To prepare the study specific data entry guideline in cooperation with the data entry specialists (if applicable)
• To prepare the Data Management Plan and the Validation Plan including manual validation checks and any amendments
• To create test data for testing the clinical database
• To run the electronic validation programs on an ongoing basis
• To review data and raise DCFs according to the CRF Monitoring Guideline and Validation Plan
• To review DCFs and update the clinical database according to DCFs and the DCC document
• To plan and follow up on the CRF/DCF collection
• To participate in SAE reconciliation meetings
• To give feedback and support CRAs regarding data collection issues, via e-mail, phone and meetings to the CRAs
• To perform quality control (QC) of the clinical database versus CRF/DCF/DCC/DTF (if applicable)
• To perform proper planning based on the overall timeline for a study.
• To integrate external data (such as laboratory and ECG data as well data from external partners) into the clinical database
• To set-up and perform batch load
• To document and ensure archiving of required study specific material
• To be responsible for the coordination of clinical data management tasks outsourced to a CRO according to study specifications (if applicable)
• To give input to the Head of Section with regard to the status of an individual clinical study as well as bottle necks
• To identify new procedures and methodologies to increase the accuracy and efficiency of departmental processes
• To develop sound, thorough recommendations for improvements
• To maintain current knowledge of relevant clinical data management developments
• To exchange relevant information and promote team work with colleagues
• To take on the responsibility as a mentor
• To assist colleagues regarding Clinical Data