CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.
For our client, an innovative and dynamic bio-pharmaceutical company headquartered in Basel, Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, we are looking for a:
Clinical Operations Manager
on a 24 months-contract, with possibility of extension.
As part of this role, you will oversee the operational aspects of clinical trials, working closely with cross-functional teams and external partners to ensure the seamless execution of Phase II and III trials.
Key Responsibilities:
1. Lead and manage trial activities, including site initiation, site closures, contract execution, and eTMF set-up and maintenance.
2. Select and manage external vendors, ensuring high-quality deliverables and performance.
3. Oversee the Contract Research Organization (CRO) to ensure timelines and quality standards are met.
4. Develop trial-related operational documents and ensure compliance with regulatory requirements.
5. Serve as the key communication link for Clinical Research Associates (CRAs) to maintain data integrity and quality.
6. Perform quality checks and ensure the Study Master File (StMF) is audit/inspection-ready.
7. Actively participate in Site Selection, Initiation Visits, and Investigators meetings, providing leadership and insights.
Qualifications & Experience:
8. Relevant working/residency permit or Swiss/EU-Citizenship required.
9. Bachelor’s degree in Life Sciences or related field (or equivalent).
10. At least 4 years of hands-on experience managing operational aspects of Phase II/III clinical trials within the pharmaceutical industry.
11. Familiarity with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
12. Experience with electronic data capture systems (e.g., eTMF, CTMS).
13. Proven experience working in cross-functional, multicultural teams.
14. Demonstrated experience in selecting and managing external service providers, including performance assessments and finance management.