Beschreibung
We are looking for a
Global Studies Manager - Clinical Trial Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Provide direction and leadership to one or more clinical operations teams
- Contribute to the development and management of the study timelines, resources, budget, risk and quality plans
- Provide clinical operations expertise to ensure operational feasibility and delivery
- Oversee forecasting of clinical/non-clinical supplies
- Deliver the operational elements of the study plan
- Provide the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Identify areas of best practice and process improvements
- Ensure study adherence to ICH/GCP and SOPs
Ihre Qualifikation
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a global environment, working with CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Good knowledge of ICH GCP
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Experience of working as part of a large team and leading small study or functional teams
- Fluent English
- Oncology experience not necessary, but an advantage
Skills:
- Clinical trial manager
Keywords: Clinical Trial Manager ICH GCP CRO SOP English