Kalin Russell
@kalinrussell
I deliver audit-ready clinical trial data from collection through regulatory submission.
What I'm looking for
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
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
Bachelor of Science, Biology
Bachelor of Science in Biology from the University of Cincinnati.
Availability
Location
Authorized to work in
Job categories
Skills
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