Senior Clinical Operations Manager
Vor 4 Tagen
CTC Resourcing Solutions AG supports pharmaceutical companies in their search for top talent. We are proud to present an exciting opportunity for a Biomarker Clinical Operations Lead.
About Our Client
We work with a global leader in drug discovery and development, known for its innovation and impact in the field of personalized healthcare. With a strong focus on R&D, they operate across various therapeutic areas and are recognized internationally for their groundbreaking work.
About the Role
We are seeking a highly motivated Biomarker Clinical Operations Lead to join our client's Pharma Product Development Global Clinical Operations department in Basel. This is a mid-senior level, full-time position.
In this role, you will provide biomarker operational expertise by planning, coordinating, and overseeing all operational activities related to biomarker and companion diagnostic samples and data for PDG clinical studies.
- Provide biomarker/IVD operational expertise to clinical study teams, ensuring operational feasibility and quality data delivery.
- Develop and oversee the Biomarker Management Plan, including all study-level biomarker operations such as vendor management, protocol input, and sample/data flow.
- Partner with stakeholders for central lab setup and manage the entire biomarker process, from sample collection to logistics.
- Lead vendor selection, define scope, budget, and performance management, and collaborate with Data Management on data formats and timelines.
- Serve as the main point of contact for biomarker operations across teams and provide technical expertise in biomarker analyses.
- Ensure compliance with regulatory standards (ICH/GCP, ISO) and conduct training on biomarker procedures.
- Address Health Authority inquiries and contribute to process improvements in biomarker operations.
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