Biospecimen Operations Specialist
Newark Metro Area, NJ
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 assigned studies' clinical biospecimen management through tracking the receipt, distribution, storage, use, and destruction; manage informed consent and sample retention times via 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.
Sponsor-side clinical trial experience in handling multiple complex early and/or late dev clinical trials with emphasis on operational, regulatory and ethical aspects of biospecimen collection and banking. Experience with complex Ph1 trials in oncology is a plus.
Experience in developing biomarker sampling plans, working with biomarker data management plans and overseeing biospecimen logistics at vendors and academic institutions.
Demonstrated 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.
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.
Applied scientific background in hematology and/or oncology disease indications; knowledge of disease mechanisms and/or signaling pathways with proven ability to apply scientific and technical expertise to biomarker research in clinical trials in an industry setting is preferred
- Bachelor s Degree in life sciences with 3-5 years professional work experience in clinical trials from the sponsor side (pharmaceutical/biotechnology R&D) or clinical site side