Manager/Senior Manager, Biomarker & Biospecimen Operations

Role: Manager/Senior Manager, Biomarker & Biospecimen Operations, overseeing biospecimen collection, tracking, shipment, vendor management, and logistics within clinical development. Responsibilities include developing management plans, collaborating with clinical operations and external labs, ensuring specimen integrity, managing data reconciliation, overseeing vendor performance, and maintaining inspection readiness. The role requires ensuring compliance with GCP, FDA, EMA regulations, and data privacy standards, while supporting audits and continuous process improvements. Qualifications: Bachelor's in Life Sciences; 5+ years (Manager) or 8+ years (Senior Manager) experience in biotech, pharma, or CRO settings with direct biospecimen management, clinical trial operations, and biomarker support. Experience with laboratory setup, biomarker assays (flow cytometry, genomics, proteomics, immune profiling), and knowledge of biospecimen guidelines (ISBER, NCI) preferred. The position involves cross-functional collaboration across Translational Medicine, Clinical Ops, Data Management, Regulatory Affairs, and external vendors. The role is based in Needham, MA, with a hybrid work schedule, and suitable for candidates authorized to work in the US. Travel and sponsorship are not required.