Overview
The Biosample Operations Manager will be accountable for the clinical and non-clinical sample planning, processing, tracking, reconciliation, and life-cycle management to maintain chain-of-custody in a GxP-compliant setting.
Responsibilities
* Manage clinical and non-clinical samples, maintain sample chain-of-custody in a GxP-compliant setting
* Accountable for clinical sample logistic planning and coordination with Clinical Operations/Biomarker sub-teams, clinical sites, external labs, vendors, and couriers to define sample processing and movement timelines needed for sample testing and transfer. Oversee all operational activities required to ensure high quality sample processing, shipping, receiving, and storage
* Manage external sample processing laboratories and vendors, responsible for contract development, sample preparation training, file transfer, document review, compliance monitoring and problem solving
* Responsible for development and review of specialty lab manuals, SOPs, equipment methods, sample labels and other controlled documents related to sample management
* Oversee clinical sample life-cycle management, responsible for innovative sample management process improvement.
* Support Translational Medicine and other assay teams as needed to provide information on sample timelines and other sample related technical and operational matters.
* Partner with Biomarker Lead to establish biomarker plan
* Coordinate with cross-functional teams to support research sample generation and allocation
* Work closely with clinical operations/CROs and/or clinical sites to resolve sample related issues in a timely manner
* Responsible for receiving and registering into the biomarker LIMS system, clinical samples which will be processed in-house.
* Coordinating shipments of clinical samples to off-site biobank for long term storage upon completion of internal testing.
Qualifications
* BS/MS in Biological/Life/Health sciences and 5+ years of relevant industrial experience
* Clinical sample chain-of-custody management, extensive experience with clinical sample collection, processing, tracking, reconciliation, and storage
* Familiarity with GxP, ICH/GCP, CAP/CLIA regulations
* Experienced with sample management Laboratory Information Management System (LIMS)
* Experienced with controlled document writing and review
* Working knowledge with clinical biomarker sample preparations and clinical pharmacokinetics
* Strong organization, planning, and time management skills
* Attention to detail, strong analytical and problem-solving skills
* Excellent oral and written communication skills
* Strong inter-person and collaboration skills
* Excellent computer skills for compiling sample/data reports/presentations
* Clinical sample chain-of-custody management, extensive experience with clinical sample collection, processing, tracking, reconciliation, and storage
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