Clinical Trial Sample Manager

BLOSSOMHILL THERAPEUTICS INC•San Diego, CA

8d•$144,968 - $169,198•Onsite

About The Position

The Clinical Trial Sample Manager is responsible for the end-to-end management of biological samples collected during clinical trials — including receipt, tracking, storage, distribution to labs/CROs, and disposal — ensuring compliance with GCP, protocol requirements, and regulatory standards. This role serves as the key liaison between clinical sites, central labs and biorepositories to guarantee sample integrity and traceability throughout the trial lifecycle. This position is an onsite role.

Requirements

Bachelor's degree in Life Sciences, Biology, Chemistry, or related field.
8 - 10 years work experience in a drug development organization.
Experience in clinical trial sample management, biobanking, or central lab operations.
Working knowledge of GCP and clinical trial regulatory requirements (FDA, ICH).
Strong organizational skills and attention to detail.
Computer competency in database and spreadsheet programs.
Excellent cross-functional communication skills (sites, CROs, labs).

Nice To Haves

Familiarity with informed consent and IRB/EC requirements related to specimen retention preferred.
Experience supporting FDA/sponsor audits or inspections preferred.
Project management experience across multiple concurrent clinical trials preferred.

Responsibilities

Oversee clinical trial sample lifecycle: collection kit design, site training, sample receipt, accessioning, storage, retrieval, shipment, and final disposition/destruction.
Reconcile sample inventory against clinical database (EDC) and protocol-specified visit/sample schedules.
Coordinate with clinical sites, CROs, and central/specialty labs to resolve sample discrepancies, missing samples, or shipment issues.
Manage cold chain logistics for domestic and international shipments (ambient, refrigerated, frozen, dry ice, LN2 vapor shippers), including customs/import-export documentation.
Ensure chain-of-custody documentation supports GCP compliance and audit-readiness.
Develop and maintain SOPs for sample handling, labeling, shipping, and biobank retention/destruction per protocol and informed consent terms.
Support development of laboratory manuals and sample collection kits for clinical trial protocols.
Track sample retention and future use consent (e.g., for genomic/biomarker research) in accordance with informed consent and IRB/EC requirements.
Serve as point of contact for sample-related queries during sponsor, FDA, or IRB audits/inspections.
Manage biorepository/biobank operations, including long-term storage and material transfer agreements (MTAs).