What are the responsibilities and job description for the Senior Manager, Sample Management position at Replimune?
Summary of job description:
The Senior Manager, Clinical Sample Management contributes to the planning and execution of biospecimen operations across clinical programs, while ensuring comprehensive data capture, integrity, and reconciliation of sample-related data. This role is pivotal in bridging logistics execution with robust sample data oversight and serves as a key contact between Clinical Operations, Clinical Data Management, Clinical Development, Translational Medicine and laboratory vendors. The position requires strong operational acumen, expertise in GxP data systems development and maintenance, and regulatory awareness related to clinical biospecimen handling.
This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 3 days per week.
- Sample Operations Leadership
- Oversee sample collection strategy including Central Lab database design and lab manual development, sample shipment, tracking, reconciliation, and disposition across global clinical studies, ensuring adherence to protocols, manuals and plans associated with biospecimen collection.
- Act as sample point-of-contact on cross-functional study teams, ensuring efficient logistics planning and execution.
- Supervise and coordinate sample data activities with labs and technology vendors.
- Manage Central Laboratory eTMF (e.g chain-of-custody documentation) and inventory sample reconciliation reports in collaboration with vendors and internal stakeholders.
- Data Oversight & Reconciliation
- Serve as the primary lead for sample data oversight, including tracking completeness, consistency, and accuracy of sample-related metadata across internal systems
- Lead sample inventory-data reconciliation efforts with internal Clinical Data Management, external central lab, and technology vendors, resolving discrepancies in a timely and compliant manner.
- Support development and implementation of data transfer agreements (DTAs) and data specifications related to sample inventory data.
- System Integration & Process Ownership
- Develop, maintain and improve biospecimen tracking systems (manual and programmatic), including design, validation support, SOP documentation, and user training.
- Identify opportunities to automate and optimize sample-data workflows, including eManifest use, barcode integration, and data visualization.
- Serve as a business process owner for biospecimen data elements across clinical systems.
- Compliance & Documentation
- Ensure biospecimen operations and data handling comply with ICH/GCP, HIPAA, GDPR, and applicable sample ethics regulations.
- Prepare and maintain audit-ready documentation, including SOPs, sample tracking reports, data reconciliation logs, and training records.
- Support internal and external audits/inspections related to inventory sample data and logistics.
Educational Requirements:
- Bachelor’s degree in scientific/technical discipline, or work equivalency. Master’s degree preferred.
Experience and Skill Requirements
- Minimum 5 years of experience in clinical trial biospecimen operations, with significant involvement in sample data tracking and reconciliation.
- Hands-on experience with biospecimen tracking tools and electronic data systems.
- Strong knowledge of clinical data principles, including DTA development, data cleaning, reconciliation, and database lock procedures.
- Familiarity with regulatory requirements governing human biospecimens and clinical research data (e.g., ICH/GCP, HIPAA, GDPR).
- Strong analytical, problem-solving, and organizational skills.
- Experience managing vendors and working cross-functionally across clinical and biomarker teams.
- Excellent written and verbal communication skills.
