Rachel Davis
Clinical Trial Manager at Immatics
- Role
- Clinical Trial Manager at Immatics
- Location
- Jeffersonville, IN, US
- LinkedIn followers
- 500 followers
About Rachel Davis
I am a clinical trial manager with over 7 years of experience in the pharmaceutical and…
Experience
Clinical Trial Manager
Sep 2023 — Present
My primary responsibility is to ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs, including but not limited to collaborating with COLs (Clinical Operations Lead) to set targets for clinical monitoring activities, and ensuring the recording of the trial in compliance with project goals. Conducting and overseeing the clinical trial site feasibility and site selection process. Creating, maintaining and implementing trial-specific plans, tools and documents required per SOP (e.g, training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan). Overseeing or performing collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements. Driving the clinical site initiation and greenlight process according to project goals. Actively contributing to clinical trial site management and engagement to establish and maintain close site relationships. Organizing and overseeing project-specific training for CRAs and clinical trial sites. Reviewing trip reports and providing day-to-day expert advice to CRAs. Reviewing progress of clinical trials, especially patient recruitment, and clinical trial data capture, and initiating appropriate actions to achieve objectives. Conducting Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA performance. Managing protocol and GCP deviations as Deviation Manager according to SOP. Proactively contributing to continuous improvement of Clinical Operation specific processes, procedure, and templates.
Education
University of Florida
Health Education and Behavior
2011 — 2012
Indiana University Bloomington
Bachelor's of Science in Kinesiology, Exercise Science
2012 — 2015
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