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 or healthcare.
10. 4 years of experience in managing operational aspects of Phase II and Phase III trials 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.
13. Previous experience working with electronic data capture eTMF and CTMS.
14. Excellent knowledge of ICH-GCP guidelines.