Biosample Operations Manager
vor 2 Wochen
BioTalent is proud to be supporting a successful and steadily growing clinical-stage biotechnology company who have established a new class of potent and precise small protein therapeutics for advanced modern medicine and to improve the management of serious diseases. We are looking to appoint a Biosample Operations Manager to manage the execution of the clinical trial sample strategies for data delivery. This is a brand new and critical role for the company. This role requires you to be on-site 1-2 days per week.
**You will be responsible for**
- Overseeing clinical sample operations and logistics, including Biomarker, PK and PD.
- Supporting the clinical biomarker and bioanalytic leaders to execute the biomarker and bioanalytics strategies in clinical trials.
- Planning, organising and overseeing the collection and shipping of biosamples from external partners.
- Monitor biosamples movement and quality from investigator sites to the central lab and then to different bioanalytical labs.
- Monitoring sample integrity and quality, and supervising all relevant sample management procedures from reconciliation, and storage, up to destruction.
- Authoring and overseeing biosample management-related documents (e.g., lab manual, sample tracking documentation) and contributing to clinical study documents.
- Assists in tracking study costs associated with sample and result management, bioanalytical assays, logistics and shipping.
**You will bring the following**
- MSc or PhD in life sciences, plus 2+ years’ experience in clinical biosample project management.
- Or BSc in life sciences, plus 4+ years’ experience in clinical biosample project management.
- Good knowledge or previous experience with clinical biomarker studies and biomarker assays.
- Experience with vendor management (clinical sites, CROs, central and bioanalytical labs).
- Experience in working under ICH/GCP guidelines.
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