Clinical Trial Sample Manager: Biobank Ops Lead

BlossomHill Therapeutics, Inc.; San Diego, Northern (CA, KY); Hybrid; USD 145,000 - 169,000; Full time

Job summary

BlossomHill Therapeutics, Inc. is seeking a Clinical Trial Sample Manager for an onsite role in San Diego, CA.

You will oversee the end-to-end management of biological samples collected during clinical trials, ensuring GCP compliance and traceability across sites, labs, and biorepositories. Key qualifications include a Bachelor's in Life Sciences and 8–10 years in drug development, experience with biobanking and central labs, and strong cross-functional communication.

Qualifications

• 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).
• 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 sample lifecycle: collection kit design, site training, receipt, storage.
• Accession, storage, retrieval, shipment, and final disposition.
• Reconcile sample inventory against clinical database and schedules.
• Coordinate with sites, CROs, and labs to resolve discrepancies.
• Manage cold chain logistics for domestic and international shipments.
• Ensure chain-of-custody documentation supports GCP compliance.
• Develop and maintain SOPs for sample handling and biobank retention.
• Support development of lab manuals and collection kits.
• Track retention and future-use consent per IRB/EC requirements.
• Serve as contact for audits/inspections.
• Manage biorepository/biobank operations and MTAs.

Skills

Strong organizational skills

Cross-functional communication

Database & spreadsheets

Education

Bachelor's degree in Life Sciences or related field

Job description

BlossomHill Therapeutics, Inc. is seeking a Clinical Trial Sample Manager for an onsite role in San Diego, CA.

You will oversee the end-to-end management of biological samples collected during clinical trials, ensuring GCP compliance and traceability across sites, labs, and biorepositories. Key qualifications include a Bachelor's in Life Sciences and 8–10 years in drug development, experience with biobanking and central labs, and strong cross-functional communication.