San Francisco Metro Area, CA
CORE JOB FUNCTIONS:
Partner with Clinical Operations and Translational Development Scientists in generating well-defined and logistically feasible biomarker plans for study protocols with alignment to informed consent documents and case report forms.
Manage and oversee the compliance of clinical biospecimen management through tracking the receipt, distribution, storage, use, and destruction.
Work hands-on to migrate studies to the Labmatrix biospecimen management system.
Ensure development and delivery of high quality training/study materials (lab manuals, quick reference guides, videos) describing biomarker sample handling for use by site personnel conducting global clinical trials.
Bachelor s degree in the life sciences or healthcare related field and at least 10 years industry experience in clinical trials and biospecimen management or Master s degree and at least 8 years experience. At least 5 years of direct supervisory experience is required.
Sponsor-side clinical trial experience in handling multiple complex Ph1 clinical trials with emphasis on operational, regulatory and ethical aspects of biospecimen collection and banking.
Extensive experience in managing a clinical trial biospecimen repository in an industry setting, with experience in building/working in biospecimen databases and working with vendor databases, IVR/EDC systems and clinical data listings to track, manage, cross-check and reconcile biospecimens. Experience with Labmatrix is a plus.
Experience in developing biomarker sampling plans, working with biomarker data management plans and overseeing biospecimen logistics at vendors and academic institutions.
Extensive laboratory experience in R&D/clinical laboratory techniques involving blood/biopsies.
Proven abilities in setting priorities, managing multiple projects, building processes and implementing complex/novel strategies in managing biospecimens.
Solid understanding of project management principles with proven ability to provide deliverables on time, manage timelines and provide issue resolution.