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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.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.

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