Clinical Operations Manager (KFR - 6659)
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
Clinical Operations Manager
on a 12 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
* 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
* Relevant working/residency permit or Swiss/EU-Citizenship required
* Bachelor’s degree in Life Sciences or related field (or equivalent).
* At least 4 years of hands‑on experience managing operational aspects of Phase II/III clinical trials within the pharmaceutical industry, and executing a wide range of clinical trial activities from study start up to clinical study report.
* Familiarity with International Conference on Harmonization‑Good Clinical Practice (ICH‑GCP) guidelines.
* Experience with electronic data capture systems (e.g., eTMF, CTMS).
* Demonstrated experience in selecting and managing external service providers, including performance assessments and finance management.
Seniority level
* Associate
Employment type
* Temporary
Job function
* Project Management, Science, and Strategy/Planning
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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