Senior Manager Biosamples Operations Lead

Senior Manager, Biosamples Operations Lead will own end-to-end biosample operations across assigned studies/programs – from operational feasibility, vendor selection, and execution of biosample operations activities through analysis and data delivery.

• Provides strategic and expert input for the operational feasibility, implementation and execution of the biosample operations activities in assigned clinical studies/programs.
• Manages biosample management activities in clinical studies with low to moderate complexity, risk, impact and reach.
• Accountable for planning, implementation and execution of biosample operations activities, ensuring proactive risks and issues management and alignment with overall clinical study timelines.
• Owns biosample operations plan and is responsible for its maintenance and adjustments during clinical study conduct.
• Leads cross‑functional biosample operations team and manages team meetings to review status of biosample operations activities, discuss risks/issues and agree on appropriate mitigation.
• Acts as the single point of contact (POC) in the Study Team on biosample operations related aspects (including biomarker and bioanalytical activities). Ensures timely status updates and escalation of risks/issues to the clinical Study Team.
• Contributes to central lab or assay lab vendor selection and qualification.
• Oversees central lab set‑up, kit management, and ongoing study‑level vendor performance.
• Manages CRO and central lab interfaces to ensure cross‑functional alignment on deliverables.
• Maintains a patient‑focus approach while delivering the complex requirements of a clinical study, balancing patient burden, sampling requirements, the complexity of collection and the cost implications.
• Responsible for overseeing the biosample lifecycle and compliance to ensure that the biosamples are collected, processed, analysed and stored with the highest degree of quality and according to applicable regulations.
• Reviews and provides input to protocols, ICFs, lab manuals, and regulatory submissions.
• Leads budget planning & forecasting for biosample activities of assigned studies.
• Ensures all activities comply with ICH‑GCP, GCLP, biobanking policies, and applicable ethical standards.
• Leads audit and inspection readiness; act as interviewee and prepare regulatory responses.
• Impacts the successful delivery of a program/study and ensures optimized execution of the biosample/biomarker operations strategy on time, within budget and required quality.
• Leverages strategic operational knowledge and serves as subject‑matter expert for current biosample management processes and regulations.

• Minimum Bachelor’s degree in Biology, Pharmaceuticals, or Life Sciences or related field.
• At least 6+ years of experience in Clinical Operations with a focus on biosample management activities in a CRO or pharma setting.
• Proven track record in central lab oversight, vendor management, and Phase I–III biosample logistics.
• Experience in CDx development and/or bioanalytical requirements would be advantageous.
• Broad experience across multiple therapeutic areas, trial phases and biosample lifecycle management.
• Comprehensive and working knowledge of GCP, GCLP guidelines and other relevant regulations and requirements for the collection, analysis and storage of clinical biosamples.
• Very good knowledge of biosample management related systems and technologies (LIMS, BRICK, CTMS, etc).
• Demonstrated experience in effectively collaborating with other functions in a complex matrix organization.
• Very good command in English language.

Please note this role is not eligible for the UK visa sponsorship.

Please note:

due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.