Beschreibung
Tasks:- Definition the objectives, strategy, milestones for preparation of Clinical Development Plans (US Clinical development focus mainly)
- Planning and conduct of clinical trials, including preparation, review or approval of associated documentation and management of budget
- Cooperation with external service providers such as CROs, laboratories, pharmacies, experts etc. as well as with 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
- Submission of Clinical Trial Applications (CTAs) to and communication with the competent national and local authorities and the relevant ethics committees
Requirements:
- profound experience as a Clinical Project Manager
- ideally at least 3 years experience as a International Clinical Project Manager
- Excellent English skills / German desirable
- ability to work with multi-disciplinary teams and external experts as well as communication, problem solving and decision making skills
Start: September 2014
Duration: 6 Months (with possibility to extend)
Location: office-based, Northern Germany
Volume: 20-40 hours / week