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Project Management

Last updated: 11:41 22/02/2013

Project Manager

Reference number: 2000 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex, Office based

Job Description

Summary:

 Act as key point of contact for assigned company Business Transformation Clients.  Be responsible for the creation and management of Client expectations in terms of agreed project deliverables to enable achievement of a positive and productive working relationship.

 The Role:

 ·         Take overall project management responsibility of assigned projects and their deliverables

·         Balance Client needs with those of the company’s Business Transformation to create and maintain a positive working relationship with both parties

·         Be conversant with the responsibilities, limitations and budget framework described by the Master Service Agreement and associated Task Orders for assigned projects

·         Facilitate proactive communications between project stakeholders to support project delivery

·         Act as consultant to the Client on the adoption of the company’s “best practice” and their achievement of Return On Investment (ROI)

·         Identify project related issues, facilitate resolution and escalate to senior management where necessary

·         Proactively identify potential process improvements to increase operational efficiency, including implementation of improvements once agreed with senior management

·         Lead identification of, and facilitate the sharing of “lessons learned” across Professional Services, the company’s Technology or the company’s Group as appropriate

·         Work with Professional Services Client Program Managers to coordinate assigned project resources to achieve agreed project timelines

·         Review client proposals and associated budgets and provide feedback to the company’s Contracts and Proposals team when requested

·         Monitor project Full Time Equivalent (FTE) actuals versus allocated budget.

·         Track project profitability, identify potential changes in scope and document as agreed with senior management

·         Update the the company Group financial tracking system on a monthly basis to indicate actuals for assigned projects and flag invoice milestones

·         Supportthe company’s Sales and Marketing team as required

·         Other activities as deemed appropriate by line manager

 

Experience/Qualifications required

Skills and Attributes:

 ·         Excellent written and verbal communication skills

·         Confidence in dealing with diverse range of customers

·         Awareness and working knowledge of relevant regulatory guidelines e.g. 21CFR11

·         Demonstrable understanding of Electronic Data Capture and Data Management systems and/or process

·         Ability to lead and direct distributed teams

·         Knowledge of project management principles and execution

 Experience:

 ·         At least 3 years’ experience of external client management

·         Experience of project budget management

Study Support Specialist

Reference number: 1979 Apply for this job Apply for this job »
Type: Contract, full time Location: Stockley Park, UK

Job Description

Summary:

 This is a demanding, responsible, varied and challenging role, which requires a basic understanding of the clinical development process.   The position would be suitable for someone who is self motivated, can multitask and is able to use clinical development systems and tools independently with an understanding as to why these tools are used.  The successful candidate will provide first class support to the Clinical Team, including senior members of the Oncology Therapy Area Management Team.

 The Role:

 Key Responsibilities

 Provide comprehensive support to Clinical Team to include but not limited to :

 ·         Provide operational support to clinical study/studies.

·         Responsible for currency and accuracy of database systems e.g. e-Track.

·         Order drug/non-drug study supplies.

·         Ensure receipt and quality of regulatory and financial documents.

·         Initiate and oversee FID activities.

·         Provide paper/electronic documentation to support modular appendices for clinical study reports.

·         Set up and maintain study files and related documentation.

 Purpose

·         Provide operational support for delivery of assigned studies or programmes on time

·         Responsible for accuracy of database systems

·         Adhere to the GCO - EU model, collaborating with internal key matrix partners and external customers

 Key Responsibilities for all Areas

·         With oversight, enter and maintain information in systems; produce standard reports; check own work and correct errors; produce and disseminate information from standard reports

·         Provide support or assistance to group/clinical teams as directed

·         Participate in the implementation of key organisational process improvement initiatives as appropriate

·         As appropriate, contribute to the standardisation and dissemination of best practices across area

·         Complete administrative duties as required

·         Resolve routine requests, escalate complex requests

 Regional Monitoring

·         With oversight, participate in efforts to assure site selection /recruitment process conducted per study timelines.  As directed, compile and send updates on the site selection recruitment process to monitors and managers.  

·         As directed by Regional Monitoring Head or monitor liaison, work with study conduct team to track study start-up and enrollment status and communicate to monitors.

·         Participate in efforts to conduct study feasibility in the region per defined processes.

 Study Management/Therapeutic Areas

·         Order, assemble, distribute, manage and track inventory of study conduct tools, drug and non-drug clinical supplies.

·         With guidance, set up, obtain, and maintain sponsor regulatory, legal, CSSO and financial files/systems per SOP, including submitting of documents to appropriate departments.

·         Assist in providing paper/electronic documentation to support modular appendices for Clinical Study Reports.

 Document Management

·         Set up, obtain, and maintain sponsor study records according to GCP/GSK processes

·         Partner with Study Management in conducting sponsor clinical study records file review

·         Archive sponsor study clinical records

 Clinical Study Agreement Team (CSAT)

·         With oversight, assist in preparing Clinical Study Agreements (CSAs) for clinical sites.

·         With oversight, maintain and update shared areas and databases for CSAs.

·         With oversight, handle routine agreement requests from Study Management and CSAT regarding CSAs.

Experience/Qualifications required

Skills:

 Minimum Requirements
 ·         Understanding of the clinical development process at study level and how parts of the process are integrated.

·         Understanding of the R&D process.

·         Computer proficiency

·         An excellent organiser, able to work well under pressure and to tight deadlines.

·         Ability to work both independently and as part of a team.

·         Personal attributes should include ability to act with discretion, initiative and diplomacy at all times.  Flexible approach with a "can do" attitude and ability to prioritise.

 Detailed Requirements

 ·         Computer proficiency in a variety of software applications

·         Basic knowledge of clinical development processes, including related functional areas and FDA regulations as required

·         Ability to work on complex or multiple project assignments

·         Demonstrated ability to manage tasks with limited oversight

·         Exhibit customer service orientation and interpersonal skills

·         Basic understanding of portions of the clinical development process such that employee is able to carry out the process as it is currently

·         Is able to use clinical development systems and tools as directed and understand why tools are used

·         Makes basic decisions regarding methods of working with guidance; complex decisions with oversight

·         Adaptability: With supervision, demonstrated ability and willingness to adjust behaviours and priorities based on changing environment

·         Integrity: Meets personal commitments and promises, and fairly represents the organisation’s capabilities, while adhering to policies and regulations; shares complete and accurate information while maintaining confidentiality

·         Communication: Demonstrated effectiveness in both oral and written communication

·         Teamwork/Collaboration: Is aware of and responds to needs of others in x cross-functional teams; actively promotes teamwork and provides input into objectives and accomplishments; offers input and ideas during team meetings

·         Customer Service Orientation:  Recognise customers, develop customer relationships by making efforts to listen to and understand the customer (both internal and external); meet or exceed customers’ needs

·         Work Standards: Sets high performance standards for self

·         Practical Learning: Assimilates and applies new knowledge and skills quickly

·         Planning and Organising: With supervision, ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards

·         Problem Assessment: Detect problems and opportunities; identify key issues and relationships from a base of information; gather all relevant information

·         Negotiation: Explore needs, concerns, and positions of others

·         Initiative: Self-starting rather than accepting passively

Director, Project Management

Reference number: 1969 Apply for this job Apply for this job »
Type: Permanent, full time Location: West Sussex

Job Description

Summary:

 To manage and lead the Technology Project Management Team, represent our client  with external and internal customers.  Lead release planning to ensure our client’s technology releases meet timeline and customer expectations

 The Role:

 Liaison with Business Development in contract preparation, bid defence and ongoing client account management

  • Act as a "customer representative" within the group to ensure adequate understanding and appreciation of customer requirements.
  • Assist in prioritisation of our client’s EDC system functionality development
  • Manage the relationship with, and expectations of our client’s customers.
  • Act as escalation point for all issues relating to our client’s customer management
  • Review escalations from the study team on a regular basis and action suitable responses.
  • Management of project assignments to individual Project Managers
  • Line management and mentoring support of assigned teams.
  • Ensure adequate training of team members relative to the tasks required
  • Lead performance appraisal reviews for assigned teams
  • Ensure project management SOPs are appropriate and followed.
  • Provide leadership support to the project management and extended teams in meeting timeline and customer expectations
  • Manage project management resource planning, forecasting, recruitment, etc
  • Ensure teams operate within assigned budget limits

Experience/Qualifications required

Skills:

 ·         Fully aware of regulatory requirements for EDC systems e.g. 21CFR11, etc

 
 Experience:

 ·         At least 12 years experience in managing external customers

·         At least 6 years direct experience of managing EDC technology teams

·         Direct experience of electronic data capture platforms and clinical trials process within a regulated Pharmaceutical environment

·         Experience of line management within a project management environment

Senior Medical Project Manager

Reference number: 1929 Apply for this job Apply for this job »
Type: Permanent, full time Location: Cambridge

Job Description

Summary:

 Our client is a global innovation, technology and product development company providing outsourced R&D consultancy services to start-ups through to global market leaders in the medical, industrial and consumer sectors. With global headquarters in Cambridge, UK and US headquarters in Cambridge, Massachusetts, our client works with end clients from front-end market needs analysis and product development through to transfer to manufacture.

 Our client is looking to recruit a technically capable and hands-on Project Manager to work on a variety of assignments for customers in the medical sector, a rapidly growing business area for our client.

Experience/Qualifications required

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