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 by performing ongoing quality checks/review;
6. Actively participate in 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:
1. Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
2. Bachelor of Science degree or equivalent University degree in life sciences or healthcare;
3. 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;
4. Experience in working in global cross-functional (matrix) and multicultural teams;
5. Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management;
6. Previous experience working with electronic data capture eTMF and CTMS;
7. Excellent knowledge of ICH-GCP guidelines.
Operation Manager • Basel and NW Switzerland, CH
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