Clinical Operations Manager
Job Title: Clinical Operations Manager
Location: Basel
Salary: Up to 70.00CHF per hour
CK QLS are recruiting for a Clinical Operations Manager, to join a growing biopharmaceutical company, at their site based just outside of Basel, in Allschwil. The position is offered on a 12 month contract with the possibility of extension.
Clinical Operations Manager Role:
1. Driving the development of the operational trial related documents and procedures, as well as setting-up the Service Providers.
2. Overseeing the deliverables of all Service Providers related activities, from specifications to close-out.
3. Managing the operational trial related activities in close collaboration with other functions.
Further Responsibilities will Include:
4. Leading the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
5. Supervising the deliverables towards the Contract Research Organization (CRO) and Service Providers selected for the trial, to ensure compliance with study protocol.
6. Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review.
Your Background:
7. Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
8. 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.
9. Experience in working in global cross-functional (matrix) and multicultural teams.
10. Experience in selecting and managing External Service Providers (ESP).
11. Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
12. Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
This is an excellent opportunity to join a growing biopharmaceutical company.