Manager, Biospecimen Management

Manager, Biospecimen Management needed to oversee biospecimen management across 5-12 clinical trials with minimal supervision. Responsibilities include developing a Specimen Management Plan, providing biospecimen input for protocol authoring to ensure operational feasibility and regulatory compliance, tracking and reconciling biospecimen status in internal/external systems, entering biospecimen requirements into contracting systems with aligned vendor documents, providing regular status updates to core clinical teams, ensuring SOP and guidance adherence, acting as liaison between clinical teams and vendors to coordinate activities and resolve issues with minimal supervision, participating in vendor audits and CAPA resolutions, maintaining study documents in inspection-ready state, contributing to cross-functional projects to optimize workflows and integrate innovative technologies, and providing training/mentorship for new colleagues while maintaining knowledge of therapeutic areas and study biospecimen requirements. The role is described with site-based occupancy, including potential for hybrid arrangements with substantial onsite presence, and travel for field-based/remote-by-design roles as needed.