Beschreibung
We are looking for a
Clinical Trial Associate-Regulatory (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Support the Regulatory Programme Managers who have strategic responsibility for CTA in clinical trial related regulatory tasks from operational perspective
- Core CTAs and amendments - planning, compilation, dispatch, coordination with internal departments and the affiliates, tracking of submissions and approvals
- Attend key SMT meetings (in the planning phase of a clinical trial) in agreement with the Programme Managers
- Interact with CROs and the affiliates for specific CTA related activities
- Support from operational perspective clinical trials in various countries on the need basis in collaboration with the program manager
- Work with the senior Trial Coordinator or the group manager on various activities like knowledge sharing and maintenance of the information
- Advice program managers on external and internal requirements for CTAs as well as changes based on the experience
Ihre Qualifikation
- Some knowledge of the clinical trials and related processes
- Regulatory knowledge/experience is a must
- Work effectively as a team member in a cross-functional team, matrix-based environment
- Ability to communicate effectively in a in multi-cultural, multi-functional environment
- Excellent administrative and project planning skills
- Pay attention to details and demonstrated commitment to deliver high quality work
- Some experience working on the clinical trial related activities
- BS/BA degree, or relevant experience in pharmaceutical industry
- Ability to coordinate multiple activities in parallel
Skills:
- Clinical trial associate
Keywords: Clinical Trial Associate regulatory CTA CRO