Manager - Biosample Operations (remote-based)
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Hobson Prior are seeking a Manager - Biosample Operations to join a biotechnology company who are applying cell and gene therapy to fight genetic diseases. This role will be on a contract basis and will allow you to work remotely.
- Accountable for planning, organizing and overseeing the collection and shipping of samples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analysable quality.
- You will maintain oversight of all study sample operational activities and regularly report on status, including sample collection and reconciling against consent.
- Manage relationships with laboratory vendors, including forecasting and tracking of study costs associated with sample management.
- Partake in reviews of protocol and Informed consent form to ensure feasibility of biological sampling and alignment with ICH/GCP and sample testing plans.
- Review laboratory manuals and laboratory specification materials to ensure accuracy and consistency with the study protocol and clinical needs.
- Partake in CRF development to ensure laboratory sample information is collected for sample tracking and reconciliation purposes.
- Manage scopes of work in support of study objectives for central and specialty labs.
- Participate in development of study-specific sample management plans to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type.
- Facilitate sample shipments and query resolution among vendors to ensure timely data delivery
- Support sample analysis data transfer, data reconciliation, and data review.
- Maintain professional knowledge of current GCP, biobanking, and sample management best practices and ethical guidelines and apply knowledge appropriately.
- Excellent written and interpersonal communication skills necessary to interface with vendors and team members.
- Effective team player and ability to collaborate with cross functional clinical study teams.
- Proven critical reasoning skills including the identification and resolution of complex problems.
- Bachelor's, or equivalent, degree in a scientific discipline.
- Demonstrated understanding of pharmaceutical regulatory requirements, both US and abroad
- Demonstrated knowledge of ICH and GCP.
- Direct experience in managing sample operations of various sample types.
- Previous experience with vendor and CRO management.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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