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Kalin Russell

@kalinrussell

I deliver audit-ready clinical trial data from collection through regulatory submission.

United States
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What I'm looking for

I'm looking to lead clinical data management activities that deliver compliant, audit-ready trial data and support successful regulatory submissions for life-changing therapies.

At Medpace, I direct end-to-end data management for Phase I–III clinical trials, delivering database locks on or ahead of schedule and achieving audit-ready data with zero major findings across 12 FDA or internal quality assurance inspections.

I develop and finalize CRF Specifications, Edit Check Specifications, Data Management Plans, External Database Import Specifications, and CRF Completion Guidelines. I oversee EDC development and validation, clinical coding, vendor transfers, data quality, and SDTM mapping for regulatory submissions.

I serve as the primary data management contact for sponsors, external data providers, and project teams while managing deadlines across study activities. I also mentor Data Coordinators on best practices, workload prioritization, and professional development.

My biology background includes hands-on cancer research in immunohistochemistry, cell culturing, protein analysis, and bioassays across bladder, breast, and ovarian cancer projects. I bring experience across oncology, cardiovascular, rare disease, infectious disease, metabolic, and CNS studies.

Experience

Work history, roles, and key accomplishments

ME
Current

Data Manager

Medpace

Feb 2023 - Present (3 years 6 months)

Authored and maintained study documents including CRF specifications, edit check specifications, and data management plans. Oversaw EDC system development and validation, managed project deadlines, and delivered 100% audit-ready data with zero major findings during inspections.

Education

Degrees, certifications, and relevant coursework

University of Cincinnati logoUC

University of Cincinnati

Bachelor of Science, Biology

Bachelor of Science in Biology from the University of Cincinnati.

Tech stack

Software and tools used professionally

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