Manage contracting with third-party lab service providers for assay development and validation, and work with business operations, procurement, and clinical operations to ensure appropriate SOWs and contracts are put in place for sample analysis of clinical trials samples.
Coordinate with bioanalytical strategy leads, clinical trial teams and third-party lab service providers to review, edit, and finalize study documents for delivery of the required lab services and ensure study timelines are met.
Provide input into clinical trial related documentation such eCRFs, ICFs, SOWs, sample collection instructions.
Work with data BSLs, data management, programmers to drive delivery of data transfer specifications and the associated data.
Manage sample tracking and logistics for sample testing, contribute to solving any sample reconciliation issues.
Address issues that arise in data transfers and drive cleaning and reconciliation of the data for data finalization
Education required:
BA/BS or higher degree with a background in medical science or relevant scientific background
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