Claire P.
Senior Site Activation Specialist
- Role
- Senior Site Activation Specialist at IQVIA
- Location
- Buffalo, NY, US
- LinkedIn followers
- 500 followers
About Claire P.
Senior Study Start-Up Specialist with 7+ years of experience supporting clinical trials and managing multi-site study start-up activities from regulatory submission through site closure.My expertise includes regulatory submissions, TMF oversight, site document management, and ensuring inspection-ready documentation across regulatory authorities including the FDA, Health Canada, and IRBs. I have experience coordinating CTA amendments, ICF revisions, and Investigator Pack releases while managing CTMS and eTMF systems to maintain timelines and compliance.I’m passionate about supporting clinical research that advances innovative therapies and improves patient outcomes.
Experience
Senior Site Activation Specialist
Sep 2022 — Present
Prepared and coordinated IRB/EC submissions, CTA amendments, and ICF revisions in compliance with FDA and Health Canada regulations.Maintained inspection-ready eTMF documentation while tracking milestones through CTMS systems.Managed study start-up and maintenance activities for multi-site clinical trials including regulatory submissions, and TMF oversight, while assisting in site activation.
Education
University at Buffalo
Bachelor of Science - BS, Medicinal and Pharmaceutical Chemistry
2015 — 2018
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