Manager/Senior Manager, Biomarker & Biospecimen Operations
Candel Therapeutics
August 18, 2026
Remote
United States
Operations
Position Summary
Candel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations to oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical development programs.
Key Responsibilities
- Serve as the operational lead for biospecimen collection, processing, shipment, inventory management, reconciliation, storage, testing, and disposition across clinical studies.
- Develop and maintain study-specific biospecimen management plans, laboratory manuals, collection schedules, handling instructions, collection worksheets, and site training materials.
- Coordinate biospecimen collection activities, courier logistics, and shipments with Clinical Operations (including support for site feasibility, investigator meetings, site initiation, and site training).
- Partner with central/specialty laboratories, biomarker vendors, biorepositories, couriers, and kit providers to ensure timely, compliant biospecimen collection, shipment, testing, and inventory management.
- Ensure specimen integrity, chain of custody, traceability, protocol compliance, and inspection readiness.
- Reconcile biospecimen data with EDC, source documentation, manifests, lab records, and vendor datasets; resolve discrepancies and data quality issues.
- Manage biomarker data transfer standards/agreements and reconciliation to ensure traceability to specimens and participants.
- Manage deviations, shipping excursions, missing/out-of-stability samples, and CAPAs (root cause + corrective/preventive actions).
- Oversee biomarker labs/CROs/service providers: vendor onboarding, contracts/SOWs, change orders, performance management, and quality oversight.
- Develop budgets, forecasts, vendor proposals, critical-path timelines, milestones, and operational deliverables.
- Ensure compliance with ICH-GCP, FDA/EMA regulations, data privacy, chain-of-custody, international shipping, and company SOPs.
Qualifications
Required
- Bachelor’s degree in Biology/Life Sciences/Clinical Laboratory Science/Biomedical Sciences or related field.
- 5+ years (Manager) or 8+ years (Senior Manager) in biotech/pharma/CRO/lab ops/clinical research.
- Direct experience managing clinical trial biospecimens with biomarker/translational medicine teams.
- Experience setting up/operating central & specialty labs, specimen repositories, and external vendors.
- Knowledge of clinical trial regulations, ICH-GCP, and biospecimen best practices.
- Strong project management and communication; advanced Excel/data tracking skills.
Preferred
- Late-stage solid tumor oncology clinical development experience.
- Biomarker assay experience (flow cytometry, genomics, proteomics, immune profiling, ctDNA, TCR sequencing, or related).
- ISBER Best Practices, NCI guidance, regulatory submissions, or health authority interactions.
Application Instructions
- All applicants must be authorized to work in the US and do not require sponsorship. Sponsorship is not available at this time.
Candel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations to oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical development programs.
Key Responsibilities
- Serve as the operational lead for biospecimen collection, processing, shipment, inventory management, reconciliation, storage, testing, and disposition across clinical studies.
- Develop and maintain study-specific biospecimen management plans, laboratory manuals, collection schedules, handling instructions, collection worksheets, and site training materials.
- Coordinate biospecimen collection activities, courier logistics, and shipments with Clinical Operations (including support for site feasibility, investigator meetings, site initiation, and site training).
- Partner with central/specialty laboratories, biomarker vendors, biorepositories, couriers, and kit providers to ensure timely, compliant biospecimen collection, shipment, testing, and inventory management.
- Ensure specimen integrity, chain of custody, traceability, protocol compliance, and inspection readiness.
- Reconcile biospecimen data with EDC, source documentation, manifests, lab records, and vendor datasets; resolve discrepancies and data quality issues.
- Manage biomarker data transfer standards/agreements and reconciliation to ensure traceability to specimens and participants.
- Manage deviations, shipping excursions, missing/out-of-stability samples, and CAPAs (root cause + corrective/preventive actions).
- Oversee biomarker labs/CROs/service providers: vendor onboarding, contracts/SOWs, change orders, performance management, and quality oversight.
- Develop budgets, forecasts, vendor proposals, critical-path timelines, milestones, and operational deliverables.
- Ensure compliance with ICH-GCP, FDA/EMA regulations, data privacy, chain-of-custody, international shipping, and company SOPs.
Qualifications
Required
- Bachelor’s degree in Biology/Life Sciences/Clinical Laboratory Science/Biomedical Sciences or related field.
- 5+ years (Manager) or 8+ years (Senior Manager) in biotech/pharma/CRO/lab ops/clinical research.
- Direct experience managing clinical trial biospecimens with biomarker/translational medicine teams.
- Experience setting up/operating central & specialty labs, specimen repositories, and external vendors.
- Knowledge of clinical trial regulations, ICH-GCP, and biospecimen best practices.
- Strong project management and communication; advanced Excel/data tracking skills.
Preferred
- Late-stage solid tumor oncology clinical development experience.
- Biomarker assay experience (flow cytometry, genomics, proteomics, immune profiling, ctDNA, TCR sequencing, or related).
- ISBER Best Practices, NCI guidance, regulatory submissions, or health authority interactions.
Application Instructions
- All applicants must be authorized to work in the US and do not require sponsorship. Sponsorship is not available at this time.