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Senior Manager, Biosample Operations (Office OR Remote)
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- DescriptionThe Senior Manager, Biosample Operations will be responsible for planning, implementing, managing, and driving biological sample logistics across Phase I-IV Clinical Trials.
- This position is in-house/hybrid or remote with ~10% domestic and international travel required.
- RESPONSIBILITIES Expertly advise on and deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP. Accountable for the implementation, execution and oversight of sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
- Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
- Track and report on sample management status and address issues proactively.
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