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von: Ctcon
Contract
Posted 24 hours ago
Recruiter: Karolina Frank
The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
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).
- 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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