Location: NorthWise Recruitment » Browse jobs

Browse jobs

Management

Last updated: 11:36 22/02/2013

Contracts and Proposals Manager

Reference number: 1998 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, Office based

Job Description

Summary:

 ·         Prepare contracts, proposals and contract amendments.  Responsibilities include proposal and change order preparation, payments schedule generation and cash flow analysis, task orders creation, internal budget and client grid completion.  

·         Provide accurate and timely tracking and reporting of contract and proposal data.

·         Submit deliverables accurately and timely.

 The Role:

 Work with Subject Matter Experts (“SMEs”) in CRO Operations, Technology and Business Operations to prepare documentation for secrecy agreement, proposals, contracts and change orders.

  • Manage the proposal or change order process, setting timelines for completion including critical path interim milestones and accountabilities, and contingencies in the event those milestones are not achieved. Proactively escalate issues and /or propose solutions in order to meet target delivery dates.
  • Use technical and creative writing skills to ensure documentation clearly articulates the company’s attributes, service offerings, and contractual limitations.
  • Use commercial, fiscal and budgetary skills to develop budgets that match the service offering included in the proposal or change order.  Includes ensuring contained costs are accurate and justifiable, and include the appropriate inflation, hourly rates and currency exchange.
  • Create or review payment schedules and terms to ensure cash neutrality and conformance with company standards.
  • Quality check deliverable prior to submission to clients.
  • Provide ad-hoc analysis as requested to assist the company management.
  • Lead special projects to improve the quality of the company’s proposals or change orders.  Sample project may include managing the company proposal module library in conjunction with SMEs, creating or maintaining pricing systems, or maintenance and reporting of standard departmental metrics or reports through corporate CRM application.

 Note : The above job description in no way states or implies these duties are the only duties performed by this employee.  The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

 

 

 

Experience/Qualifications required

Skills and Attributes:

 Outstanding business, technical and sales-oriented writing skills - ability to convincingly and articulately convey technical and/or operational expertise, services, and attributes.

  • Experience developing or analysing pricing in the CRO, Pharmaceutical or Software industries.
  • Ability to prioritise and manage numerous short-term projects quickly, accurately, and efficiently in a fast paced environment and under intense deadline pressure.
  • Ability to advise and interact with all levels of management.
  • Demonstrated commercial, fiscal, analytical and mathematical skills.
  • Strong Outlook, Word, Excel and MS Office skills.
  • Superior organisational skills.
  • Excellent communication and interpersonal skills.

·         Strong leadership skills.

·         Diligence, flexibility, attention to detail.

 Experience:

  • Two (2) years’ experience in a CRO, pharma/biotech outsourcing or software company in a similar role.

 Qualifications:

 Bachelor's Degree in a business field, or a life sciences degree with equivalent work experience

Global Studies Manager

Reference number: 1963 Apply for this job Apply for this job »
Type: Permanent, full time Location: Welwyn Garden City, UK

Job Description

Main Responsibilities and Accountabilities:

 Provides direction and leadership to one or more clinical operations teams

• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.

• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.

• Creates team culture and promotes team spirit.

• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.

• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.

• Oversees the development and maintenance of study specific manuals created by the GSA.

Contributes to the development and management of the study timelines, resources, budget, risk and quality plans

• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.

• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.

• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 

• Provides operational input into the development of protocol feasibility questionnaires. 

Provides clinical operations expertise to ensure operational feasibility and delivery

• Leads the development and finalization of site feasibility questionnaires.

• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.

• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.

• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.

Oversees forecasting of clinical/non-clinical supplies

• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.

• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.

Delivers the operational elements of the study plan

• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.

• Ensures that reporting of SUSARs is established and maintained for the duration of the study.

• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.

• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.

• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.

• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.

• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.

• Provides operational input into the development and tracking of SMT goals.

 •  Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work

• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.

• Develops and executes appropriate site and CRO/vendor audit and quality plans.

 • Identifies areas of best practice and process improvements

• Participates in Pharma Development Operations initiatives and programs as assigned.

• Maintains oversight and ensures consistency of the operational aspects across studies within a project.

Ensures study adherence to ICH/GCP and SOPs

Experience/Qualifications required

Qualifications:

Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.

Skills & Knowledge:

 Experience

·          Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.

·          Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.

·          Good knowledge of ICH GCP

·          Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.

·          Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.

·          Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.

 

Competencies

•      Project Management

•      Collaboration and Teamwork

•      Negotiating

•      Communication

•      Personal Organization

Business Development Manager/Director - Technology

Reference number: 1961 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex or Home

Job Description

Background:

 Our client is an eClinical software and mobile appliances provider. It offers its own platform for eTrial design, paper and eData capture, monitoring, coding, data management and reporting. The platform’s unique architecture uses distributed computing and mobile technologies to provide the freedom to manage any type of data type, for any protocol, anywhere.  It is purpose-built to respond on-demand to the dynamic needs of study teams: 

¡  Support both simple and complex protocols right out of the box

¡  Operate globally wherever investigators and patients are located

¡  Incrementally go live, speeding study start-up

¡  Execute amendments without system downtime or site interruption

¡  Analyse results through real-time reporting of global clinical data

 Summary:

 This position will be responsible for developing and closing sales of our client’s software product. It will be responsible for all parts of the sales process: generation and development of leads, inside and outside sales calls, tailoring of presentations and proposals to specific customer needs and facilitation of proposals through customers’ approval processes.

The successful candidate will be a relentless new business “hunter” with established connections in the pharmaceutical, biotechnology or life sciences technology sales marketplace. He or she will be excited about the prospect of helping customers break away from limited legacy, “siloed” technology models by moving to our client’s technology.

 The Role:

 The Business Development Manager/Director will perform activities from lead generation to sales closure in line with quarterly and annual sales targets and quotas.

¡  Prospect (i.e., “hunt”) for new accounts, focusing on areas of our client’s technology’s competitive differentiation, maintaining clear account records of points of contact, potential budgets, etc.

¡  Qualify and develop leads into closed technology sales: on-premise licensing, software-as-a-service licensing and professional services sales

¡  Manage tailoring of individual account plans, inclusive of proactive customer proposals and prepared responses to customer RFIs, RFPs and RFQs

¡  Manage customer expectations in line with our client’s technology value proposition and capabilities

¡  Monitor industry trends and quickly adapt to changing developments

¡  Comply with our client’s business practices regarding capture and reporting of opportunities and sales.

 This position will report to our client’s Senior Director of Business Development.

Experience/Qualifications required

Skills and Experience:

 Necessary

¡  Demonstrated ability to build and maintain a strong sales funnel

¡  Demonstrated experience directly selling software and information services-based solutions in R&D divisions of pharmaceutical, biotech or life sciences organisations

¡  Demonstrated experience selling at multiple levels and entry points into life sciences organisations: clinical, IT and financial—from line manager to executive

¡  Proven track record of consistent quota achievement

¡  Demonstration of excellent written and oral communication skills, including the ability to tailor presentations and proposals to specific customer needs

¡  Willingness to travel 20-40% (to see customers, attend conferences, etc.)

 Desirable

¡  Experience selling electronic data capture (EDC) or clinical data management system (CDMS) technology

¡  Experience selling Software-as-a-Service (SaaS), Cloud Computing, or Application Service Provider (ASP) technology

¡  Familiarity with Internet-based, mobile or appliance technologies

¡  Educational background (or equivalent experience) inclusive of medicine, biology, biotechnology or similar field

¡  Ability and desire to work in an entrepreneurial environment

 Qualifications:

 ¡  Bachelor’s degree in Business Administration, Technology or Marketing (or equivalent industry experience).

Global Head of Database Programming

Reference number: 1921 Apply for this job Apply for this job »
Type: Permanent, full time Location: Sussex

Job Description

Job Description:

We are assisting a specialist CRO in finding a Global Head/Manager of Database Programming.

 Core Responsibilities:

To develop the Database Configuration and SAS Programming Group on a global (US and EU) basis. To manage the build, maintenance, ongoing support of trial database applications, and the generation and maintenance of database listings for data management operations according to agreed timelines and quality targets.

 

Principal Accountabilities:

• To recruit and train suitable personnel for the Database Configuration and SAS Programming Group, developing a US group of adequate size and training to act independently of other offices (US secondment priority)

• Manage priorities for the global department to ensure delivery of all trial database applications, data listings (monitoring, coding and safety), reports and delivery of validated reporting shells according to agreed timelines

• Manage, coach, develop and co-ordinate existing members of department (US and UK).

• Coordinates trial database application delivery with software release structure.

• Instrumental in the development of company and/or sponsor standards to allow rapid accurate database configuration.

• Provide input to functional requirements to support the quality and productivity of database configuration.

• Maintain up-to-date knowledge of new developments/functionality specific to database configuration of software as new versions are developed and convey this knowledge to others

• Develops departmental processes and procedures. Leads process initiatives as required.

• Creates screens, visit schedules according to annotated CRF and database specifications.

• Programs and tests validation checks according to Data Management Plan (DMP) specifications.

• Provides input as appropriate into all meetings, discussions and activities pertaining to  database configuration and SAS mapping

• Ensures timesheets are accurate and updated regularly.

• Support Business Development activities as required

Experience/Qualifications required

Candidate Requirements:

• Degree in life sciences, computer sciences, pharmacy, nursing or nursing qualification (e.g. RN) or equivalent relevant experience.

• Demonstrated experience in the disciplines of data management/database programming.

• Previous experience of managing and developing a team.

• Exposure to concepts of clinical database applications and platforms with a knowledge of eDM and eDC processes

• Foreign language skills would be advantageous.

 

Attributes Include:

• Good organisational skills, plus an understanding of resource & budgeting

• Good interpersonal and communication skills and the ability to operate effectively in a global working environment.

• Good people management and coaching skills

• Work calmly under pressure and meet deadlines

• Professional, positive and enthusiastic attitude

• A good investigative and meticulous approach to all activities and tasks

• Transparent approach, clear and precise

• Team player

• Contribute to improving the effectiveness of the organisation such as developing new processes, systems and client relations

• Work effectively and efficiently with internal partners

 

This is a permanent position.