Senior Manager, Clinical Biomarker Operations

Role Summary

The Department of Research and Translational Medicine is seeking a Clinical Biomarker Operations Sr. Manager. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, contracts, and budget management.

Key Responsibilities

• Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition.
• Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications.
• Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions.
• Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance.
• Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships.
• Support QA in vendor audit and inspection activities.
• Support activities related to biomarker budget planning and tracking of accruals.
• Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards.
• Continuously identify and build best practices for process improvements.
• Ensure high quality data generation by overseeing sample integrity and external collaborations.

Ideal Candidate

• MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role.
• Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage.