Senior Manager, Clinical Biomarker Operations
New
A
Apogee TherapeuticsBiotechnology
Location: RemoteFull-TimeManager
Salary$150,000-$170,000 / year
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Job Details
- Experience
- MS or higher with > 3 years or BS with >5 years of direct experience
- Required Skills
- Budget management
Requirements
- MS or higher with > 3 years or BS with > 5 years of direct experience in a biomarker operations role.
- Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance.
- Significant experience with CRO oversight, including contract management, SOW reviews, activity/accrual tracking, and final reconciliation.
- Experienced in all phases of clinical trials; Phase 3 experience is a plus.
- Good understanding of biomarker assays including flow cytometry, genomics, and protein-based assays.
- Ability to travel a minimum of ~4 times per year for in-person meetings and workshops.
- Strong emotional intelligence with the ability to collaborate effectively in cross-functional teams.
- Experience in I&I indications.
- Flexible and able to manage multiple, competing priorities under tight timelines.
Responsibilities
- Plan, track, and manage logistics around biomarker sample collection across all clinical trials, overseeing shipments, testing, reconciliation, and final disposition.
- Ensure adherence to clinical study protocols, contributing to biospecimen collection guidelines in protocols, ICFs, and lab manuals.
- Lead finalization of data transfer specifications and maintain sample inventories for short-term and long-term storage.
- Collaborate with Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance teams.
- Coordinate review and finalization of MSAs, legal agreements, and contracts related to clinical biomarker activities.
- Support vendor selection, performance management, audit, and inspection activities to ensure compliance with company standards.
- Manage biomarker budget planning and tracking of accruals.
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