Description
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:
- Provides direction and leadership to one or more clinical operations teams
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Oversees forecasting of clinical/non-clinical supplies
- Delivers the operational elements of the study plan
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Identifies areas of best practice and process improvements
- Ensures 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 and/or including monitoring or leading affiliate teams, working with vendors and/or 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, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitment
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Fluent English
- Experience in CNS an advantage
Skills:
- Clinical trial manager