Beschreibung
Good Evening,I am looking for a Clinical Trial Leader for a big pharmaceutical company in south Bavaria (Germany)- to start full time for a 2 year period, as soon as possible. This ist a labour leasing or a transfer of personnel (Arbeitnehmerüberlassung) position.
The tasks:
1) Operational tasks, manage and lead of the Clinical Trial Team
- Provide input into protocol to ensure effective delivery of the trial goals
- Communicate the information of the protocol to the CRO and Country Affiliates
2) Optimisation of patient's accessibility, allocation of the recourses and the country development
- Creating of site screening tool for country feasibility, obtaining approvals at boards, and build allocation scenarios based on feedback of CRO's
3) Implementation, Preparation and Management of Vendors
- Lead vendor selection with suitable CTT members and consultation of CRO manager
- Development of trial specification
4) Coordinating and managing the test articles and non-drug supplies across regions
- Cooperate with Clinical Trial Supply Managers to insure all facets of the test article are managed throughout the trial
- Set up of Interactive Response Technology specifications and testing to ensure coordination of test article across regions
5) Managing of the overall trial conduct to trial close out
- Oversee and manage resolutions of trial operational issues
- Communicate to the Clinical Trial Team and country affiliates on timelines
6) Ease trial close out activities through:
- Operational support for clinical trial study report e.g. appendices
- Ensure fully close out of all sites (vendor, material and budget)
- Ensure the completion of final drug accountability
Timeframe:
· Start: asap
· 5 Days per Week
· Timeframe: 24Month