Main Responsibilities:
1. Being responsible for the assigned global trials;
2. Manage the operational trial related activities in close collaboration with other functions, such as site initiations, site closures, import/export licenses for materials submissions to Ethics Committees/Institutional Review Boards;
3. Manage the selection of External Service Providers in collaboration with other functions;
4. Supervise the deliverables towards the Contract Research Organization (CRO) to ensure compliance with study protocol and in accordance with scope of work;
5. Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review;
6. Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits;
7. Assume responsibility for other project or trial-related duties as assigned.
Qualifications and Experience:
8. Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
9. Bachelor of Science degree or equivalent University degree in life sciences;
10. At least 4 years of experience in managing operational aspects of Phase II and Phase III trials within the pharmaceutical industry, and executing a wide range of clinical trial activities from study start up to clinical study report;
11. Experience in working in global cross-functional (matrix) and multicultural teams;
12. Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.