Beschreibung
My client, a pharmaceutical company in Northern Germany, is currently looking for an International Clinical Project Manager who is responsible for clinical program development strategies, planning and the supervision of assigned (clinical) trials/ projects and their conduct according to national and international legal and ethical requirements. This position is office-based (in North Germany) and requires the candidate to be available 20-40 hours per week with a contract length of 6 months (with the possibility to extend).Tasks and Responsibilities:
- Definition the objectives, strategy, milestones for preparation of Clinical Development Plans
- Planning and conduct of clinical trials / experimental and cosmetic testing / investigations with medical devices, including preparation, review or approval of associated documentation and management of budget
- Cooperation with external service providers, investigators and investigational sites
- Defines study protocol outlines, responsible for clinical content for key project related documents (IB, briefing packages for regulatory authorities, ISE, ISS)
- Leading the clinical study sub-teams
- Cooperation with other departments
- Submission of Clinical Trial Applications (CTAs) to and communication with the competent national and local authorities and the relevant ethics committees
- Provision of clinical approval documents
- Processing of the clinical part of deficiency letters
- Preparation of reports as part of variations to existing Marketing Authorizations
- Internal and external presentation of the results of the clinical trials (e.g. at congresses and other meetings)
- Preparation and review of publications concerning clinical trials
- Assessment of the clinical part of possible in-licensing offers and new products
- Support in the preparation of the Company Core Safety Information (CCSI)
LOCATION: NORTH GERMANY
START: SEPTEMBER 2014
RATE: NEGOTIABLE
LENGTH: 6 MONTHS
If you are interested, please give me a call () or write me an email: