Clinical Operations Manager (6115)
The Life Science Career Network
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Clinical Operations Manager
on a 12 months-contract, with possibility of extension afterwards.
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 a Clinical Operations Manager for a 12 months-contract based in Basel area.
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:
- Trial Operations Management: Lead and manage trial activities, including site initiation, site closures, contract execution, and eTMF set-up and maintenance.
- Vendor Management: Select and manage external vendors, ensuring high-quality deliverables and performance.
- CRO Supervision: Oversee the Contract Research Organization (CRO) to ensure timelines and quality standards are met.
- Operational Documentation: Develop trial-related operational documents and ensure compliance with regulatory requirements.
- CRA Support: Serve as the key communication link for Clinical Research Associates (CRAs) to maintain data integrity and quality.
- Quality Assurance: Perform quality checks and ensure the Study Master File (StMF) is audit/inspection-ready.
- Site Engagement: Actively participate in Site Selection, Initiation Visits, and Investigators meetings, providing leadership and insights.
Qualifications & Experience:
- Swiss working/residency permit and/or Swiss/EU Citizenship required.
- A Bachelor’s degree in Life Sciences or related field (or equivalent).
- At least 3 years of hands-on experience managing operational aspects of Phase II/III clinical trials.
- Familiarity with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
- Experience with electronic data capture systems (e.g., eTMF, CTMS).
- Proven experience working in cross-functional, multicultural teams.
- Demonstrated experience in selecting and managing external service providers, including performance assessments and finance management.
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