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Senior Clinical Operations Manager – 6575
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Clinical Operations Manager for a 12 months-contract with extension based in Basel area.
The Clinical Operations Manager is driving the development of the operational trial related documents and procedures, as well as setting-up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out. For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESPs.
Main Responsibilities:
* Being responsible for the assigned global trials;
* 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
* Manage the selection of External Service Providers in collaboration with other functions
* Supervise the deliverables towards the Contract Research Organization (CRO) to ensure compliance with study protocol and in accordance with scope of work
* Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review
* Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits
* Assume responsibility for other project or trial-related duties as assigned
Qualifications and Experience:
* Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
* Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
* 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.
* Experience in working in global cross-functional (matrix) and multicultural teams.
* Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
* Previous experience working with electronic data capture eTMF and CTMS.
* Excellent knowledge of ICH-GCP guidelines.
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