Proclinical is seeking a Biosample Operations Manager (Sr.) to join a leading biotech company located in San Francisco, CA. This role is on a contract basis and offers the option of working remotely.
The Biosample Operations Manager is responsible for the planning and coordination of all activities associated with handling of clinical trial biosamples, including samples for biomarkers, pharmacogenetic, immunogenicity, and pharmacokinetic testing. Activities include planning and oversight of collection, handling, shipment, and storage.
Must be eligible to work in the US.
Job Responsibilities:
- Plans and oversees all logistics (i.e., collection, handling, shipment, reporting, and storage) of human biosamples for assigned clinical trials
- Responsible for the operational specifications for central and specialty laboratories and associated study documents, including laboratory manuals.
- Key contributor for laboratory contracts and budgets
- Oversees shipment and analysis schedules, ensuring that samples are analyzed, and results are reported according to required timelines
- Ensures biosample handling complies with the protocol, SOPs, and ICH GCP Guidelines
- Contributes to development of informed consent documents and supports the team with responding to IRB/IEC questions regarding biosample processing. Ensures that all human biosamples are collected, processed, and stored in accordance with the informed consent
- Trains study team members, vendor, and site personnel, in biosample handling requirements
- Works closely with the Clinical Biomarker team in the above activities
- Contributes to process improvement initiatives when required
Skills and Requirements:
- Bachelor's degree in Life Sciences required; graduate degree preferred
- At least 5 years' experience in clinical research
- Solid knowledge of biomarker and analytical processes
- Strong understanding of ethical, legal, and logistical considerations for handling human blood and tissue specimens
- Working knowledge of ICH/GCP
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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