As the Biosample Outsourcing Manager, you will be responsible for the strategic planning, execution, and oversight of biosample-related outsourcing activities across clinical programs. You’ll serve as the key liaison between internal teams and external vendors (e.g., central labs, biorepositories, courier services, specialty labs), ensuring high-quality, timely, and compliant biosample management to support clinical development and translational research.
Key Responsibilities
Vendor Strategy & Selection
* Lead RFPs, vendor evaluations, and selection processes for biosample-related services
* Negotiate contracts, budgets, and service level agreements (SLAs)
* Establish and maintain preferred vendor relationships
Operational Oversight
* Manage biosample logistics across global clinical trials, including collection, shipment, tracking, storage, and analysis
* Monitor vendor performance and KPIs; drive continuous improvement
* Resolve operational issues and ensure compliance with GCP, ICH, and internal SOPs
Cross-Functional Collaboration
* Partner with Clinical Operations, Biomarker Sciences, Bioanalytical, Regulatory, and Legal teams
* Support protocol development, sample handling plans, and lab manuals
* Provide biosample input during study startup and execution phases
Governance & Compliance
* Ensure biosample activities align with ethical, regulatory, and privacy standards (e.g., GDPR, HIPAA)
* Maintain audit readiness and support inspections as needed
* Contribute to biosample governance frameworks and risk mitigation strategies
Qualifications
* Bachelor’s or Master’s degree in Life Sciences, Biomedical Sciences, or related field
* Previous experience in clinical biosample management or outsourcing in biotech/pharma
* Strong knowledge of clinical trial processes, GCP, and biosample lifecycle
* Experience managing vendors and contracts in a global setting
* Excellent project management, communication, and negotiation skills
* Ability to thrive in a fast-paced, matrixed environment