Oversee and manage the complete lifecycle of biospecimens collected for early phase clinical studies with minimal supervision.
Core Clinical Team member responsible for providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.).
Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed.
Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking.
Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with support.
Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed.
Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines.
Maintain intermediate working knowledge of compound and study related biospecimen requirements.
Ensure completion of individual Study Transition Forms
Qualification & Experience
Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.
Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent.