Summary:
A growing biopharmaceutical organization is seeking a highly motivated Biosample Operations Manager to support clinical development programs. This role provides leadership in clinical trial execution and laboratory vendor oversight to ensure the smooth management of biosample collection, tracking, and analysis in alignment with study objectives. The ideal candidate will have experience managing laboratory vendors, working cross-functionally with internal teams, and contributing to biomarker and pharmacology strategies.

Key Responsibilities:

• Build and maintain collaborative relationships with internal teams, contract research organizations (CROs), and laboratory service providers.
• Oversee vendor selection, contract management, and scope-of-work agreements for biosample-related activities.
• Implement and manage biosample analysis plans, ensuring compliance with study protocols and informed consent requirements.
• Lead sample logistics operations, including collection, processing, shipment, testing, reconciliation, and final disposition.
• Support the execution of biomarker and pharmacology strategies, ensuring alignment with clinical study needs.
• Resolve discrepancies related to sample handling and data integrity.
• Develop and optimize documentation such as protocols, laboratory manuals, informed consent forms, and case report forms.
• Provide education and training for sample collection and shipment to investigator sites, vendors, and internal teams.
• Identify areas for process improvements and contribute to operational efficiency initiatives.

Qualifications & Skills:

• Bachelor’s degree in life sciences or a related discipline; 8-10 years of experience in clinical and drug development.
• Hands-on experience in clinical or biological laboratory settings with biosample processing and analysis.
• Strong background in clinical trial management, particularly in oncology and/or precision medicine.
• Familiarity with regulatory requirements, including FDA, ICH, and GCP guidelines.
• Experience with early-phase oncology trials is preferred.
• Self-motivated, detail-oriented, and results-driven team player.
• Strong organizational and communication skills with a problem-solving mindset.
• Proficiency in clinical trial software and tools such as MS Excel, MS Project, Smartsheet, Adobe, EDC, CTMS, and TMF.
• Ability to prioritize tasks, analyze problems, and propose effective solutions.

This position offers an opportunity to work in a dynamic and fast-paced environment, contributing to groundbreaking research and clinical development efforts.