Senior Vendor Laboratory Manager

Location: San Rafael, CA (Open to Remote)

12 month assignment (Great potential to extend)

Pay Rate: $70/hr.

On behalf of our pharmaceutical client specializing in therapeutics for patients dealing with life threatening rare genetic diseases. The Senior Vendor Laboratory Manager is a critical member of the Clinical Laboratory & Biospecimen Management team, which operates within Strategic Research and Development Operations. CLBM oversees Central and Specialty Laboratory vendors involved in all stages of clinical trials, ensuring the ethical collection, analysis, and lifecycle tracking of human biospecimens.

Key Responsibilities:

• Act as Vendor Laboratory Manager for select programs or studies, independently performing all related responsibilities.
• Contribute to the selection of central and specialty lab vendors.
• Support study start-up activities, clinical timeline management, and contract modeling.
• Partner with Global Study Operations, Business Operations, Data Management Sciences, and Translational Sciences to manage lab vendor/biospecimen close-out activities.
• Ensure vendor deliverables align with clinical timelines and intended assay use based on clinical protocols and regulatory requirements.
• Perform financial and contractual reviews for studies, including modeling, invoicing, and accruals.
• Identify, troubleshoot, and resolve operational issues with vendors in collaboration with clinical and translational sciences teams.
• Review and manage informed consent documents as they relate to biospecimen management.
• Provide training and mentorship to manager-level staff.
• Actively contribute to high-level cross-functional conversations and strategic planning sessions.
• Serve as the point of contact for research colleagues regarding the availability and integrity of biospecimens for future use.
• Review disposal requests and participate in inquiries related to biospecimen integrity.
• Ensure compliance with ICH GCP, GLP, GDPR, and other applicable regulations.

Education and Experience Requirements:

• PhD in Life Sciences or related field with 2+ years of project management or clinical operations experience. Master’s Degree in Life Sciences or related field with 5+ years of project management or clinical operations experience. Bachelor’s Degree in Life Sciences or related field with 7+ years of project management or clinical operations experience.
• Experience with clinical or biological laboratories, including processing and analyzing biological samples.
• Strong understanding of human biospecimens, storage/shipment conditions, and biomarker operations.
• Professional experience in the pharmaceutical/biotechnology industry, clinical research, or clinical/diagnostic laboratories.
• Knowledge of clinical drug development, ICH GCP, GLP, IVDR 2017/746, and GDPR.
• Expertise in risk identification, mitigation planning, and issue resolution.