Clinical Study Manager

Salary Range: $144,968.00 To $169,198.00 Annually About BlossomHill Therapeutics: BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. 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. Key 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). 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. The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. E-Verify: BlossomHill Therapeutics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) to resolve the issue. Opt-Out Request Honored #J-18808-Ljbffr