The role of Manager within the Translational Medicine (TM) organization is to support clinical trials at all phases by working collaboratively across teams to enable key clinical bioanalysis deliverables. The position requires strategic thinking to foster open-communication and partnership with Clinical Operations, Data Management and outside vendors to enable data deliverables. The role will be responsible for creation and curation of reports summarizing various analytics to TM leadership team.

Duties/Responsibilities

• Coordinate/manage Translational Medicine’s key clinical bioanalysis deliverables for all clinical studies
  • Work with all bioanalysis managers across all method technical platforms to develop strategy for bioanalysis across programs
  • Compile information and generate dashboard for clinical teams and stake holders on sample testing initiation, progress per plan or delay, and completion
  • Contribute to the development of new tracking systems, new processes, process improvement initiatives and standards, promoting ideas for optimization
  • Track sample testing, data QC or QA review, data submission, and bioanalysis reports
  • Monitor vendor KPI, Deviations and CAPA, QA and Regulatory compliance for all bioanalysis CROs as part of vendor oversight and management
  • Develop and maintain TM risk assessment and tracking
• Communicate high level information at clinical meetings
• Work with Translational Medicine Leadership and serves as Translational Medicine’s representative to facilitate discussions with Clinical and Development Operation, Data Management, Biostatistics, Clinical Pharmacology, Medical Writing, PV/Safety, and Regulatory for all bioanalysis deliverables towards CSR, IB, regulatory submission documents, external presentations/publications.
• Assist in extracting key information in protocol and protocol amendments that requires Translational Medicine to update sample analysis plan and adjust timelines for key deliverables. Share information with bioanalysis managers
• Engage in discussions on 2026 bioanalysis functional goals and objectives with alignment on priorities to support project, program, and corporate goals. Gain agreement with Program Management.
• Develop and implement streamlined workflow with Translational Medicine leadership team.

Requirements

Skills/Abilities

• Excellent verbal and written communication skills.
• Excellent organizational and interpersonal skills with attention to detail and the ability to work well independently as well as in a team.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.
• Good understanding of GLP/GCP regulations and their application in bioanalytical contexts
• Proficient with Microsoft Office Suite or related software.

Education / Certifications

MS/BS or BA in applicable field

Experience

6+ years relevant experience.

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

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