Manager/Senior Manager, Biomarker & Biospecimen Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the collection, tracking, shipment, reconciliation, vendor management, and logistics of biospecimens across clinical development programs.

• Act as the operational lead for managing biospecimen inventories and tracking systems utilized in clinical studies.

• Create and uphold study-specific biospecimen management plans, laboratory manuals, schedules, handling instructions, worksheets, training materials, and operational documentation.

• Collaborate with Clinical Operations on aspects of biospecimen collection, coordination of courier services, shipment logistics, feasibility assessments, investigator meetings, site initiation visits, and training at sites.

• Coordinate efforts with central laboratories, specialty laboratories, biomarker vendors, biorepositories, couriers, and kit providers.

• Ensure the integrity of specimens, maintain the chain of custody, ensure traceability, compliance with protocols, and readiness for inspections.

• Reconcile biospecimen data with electronic data capture (EDC) records, source documentation, shipment manifests, laboratory records, and vendor datasets.

• Support the implementation of biomarker data transfer standards, data transfer agreements, and processes for data reconciliation.

• Manage sample deviations, shipping excursions, out-of-stability events, missing samples, protocol deviations, and compliance issues at sites, including conducting root cause investigations and corrective action plans (CAPAs).

• Provide operational oversight for biomarker laboratories, contract research organizations (CROs), and external service providers, including onboarding, contracts, statements of work (SOWs), change orders, performance management, and quality oversight.

• Develop and manage budgets, forecasts, vendor proposals, critical-path timelines, study milestones, and operational deliverables.

• Ensure adherence to ICH-GCP, FDA and EMA regulations, data privacy requirements, chain-of-custody standards, international shipping regulations, and company standard operating procedures (SOPs).

• Maintain study documentation that is inspection-ready and support audits, inspections, quality investigations, and ongoing improvements.

• Act as a liaison among Translational Medicine, Clinical Operations, Data Management, Biostatistics, Clinical Development, Regulatory Affairs, Quality, and external vendors.

• Promote process standardization, operational excellence, and continuous improvement in biomarker operations.

⛳️ Requirements

• Bachelor’s degree in Biology, Life Sciences, Clinical Laboratory Science, Biomedical Sciences, or a related field.

• A minimum of 5 years of relevant experience for Manager level or 8 years for Senior Manager level in biotechnology, pharmaceuticals, CROs, laboratory operations, or clinical research environments.

• Direct experience in managing clinical trial biospecimens and collaborating with biomarker or translational medicine teams.

• Experience in setting up and operating central laboratories, specialty testing laboratories, specimen repositories, and working with external vendors.

• Knowledge of clinical trial regulations, ICH-GCP, and best practices in biospecimen operations.

• Strong skills in project management, organization, problem-solving, written communication, and verbal communication.

• Advanced proficiency in Excel and data tracking tools.

• All applicants must be authorized to work in the US and will not require sponsorship.

• Preferred: Experience in late-stage solid tumor oncology clinical development.

• Preferred: Familiarity with biomarker assays such as flow cytometry, genomics, proteomics, immune profiling, ctDNA, TCR sequencing, or related technologies.

• Preferred: Knowledge of ISBER Best Practices, NCI biospecimen guidance, regulatory submissions, or interactions with health authorities.

🏝️ Benefits

• Supportive, mission-driven work environment.

• Transparent and empowering leadership.

• Flexible workplace culture.

• Emphasis on trust, flexibility, and accountability.

• SMS/text message updates regarding job application status, interview invitations, reminders, and related information.