Pharmaceutical Jobs - Clinical Research Jobs

Position

Senior Clinical Project Manager-Switzerland

Company

Key People Ltd

Location

TBC

Country

Switzerland

Job Description

Job Description Senior Clinical Project Manager

Responsible for all operational aspects of 1 or more clinical trial(s) (Phase II through lifecycle management) under the leadership of Clinical Trial Leader. Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.

1. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
2. Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
3. Prepare training materials and presentations related to the planning and conduct of the trial.
4. Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
5. Manage interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and the client’s local medical organizations.
6. Accountable for accuracy of trial information in all trial databases and tracking systems.
7. Support the development, management and tracking of trial budget working closely with the Therapy Area (TA) program operations group.
8. Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.
9. Point of contact for managing/answering questions related to trial procedures and patients’ eligibility.
10. Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. Participate in International Clinical Team meetings.
11. Contribute to program level activities (e.g., tracking of CD&MA brand-related publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
12. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
13. Contribute to talent and career development of TA staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for CD&MA training programs.
Minimum requirements Successful completion of trial operational activities which enable CTT to fulfil deliverables according to agreed timelines and budget.

• Advanced degree or equivalent education/degree in life science/healthcare required accompanied with ≥ 2 years experience in clinical research.

• Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with ≥ 4 years experience in clinical research.

• Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
• Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Proven networking skills and ability to train colleagues.
• Proven ability to work both independently or in a team setting, including a matrix environment
• Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
• Knowledge of principles for trial budgeting.
• Basic knowledge of TA preferable.

For immediate consideration, please email your CV with salary requirements

Company Profile

Key People is a recruitment consultancy with a reputation for providing good value that’s been built up over 15 years. Clients come to us for three main reasons: > We achieve results faster > Our candidates really are a cut above > We add greater value We think it’s because we’re a private company driven by clients, not by shareholders. We focus on a number of key industry sectors and have specialist teams, each dedicated to one specific market. Over the years, we’ve created an extensive network of invaluable industry contacts. This means we know exactly where to gain access to the very best people – talented professionals with specialist skills we know you’ll want to meet. For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you’ll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you’ll get the chance to work for some prestigious, blue-chip organisations.

Job Type

Full Time

Salary

Upto 0 € Per Month

Skills Required

GCP-ICH, Project management-Clinical Research

Reference

kpCPMjip03

Posted On

02 March 2010

Last Date to Apply

02 April 2010

Important Notice

For jobs based in the EU it is unlawful to employ a person who does not have permission to live and work in the EU. Unless the job advert states otherwise, please ensure you have this permission before applying.

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