Shauna O'Donnell
innovative clinical leader with a passion for improving human health@ Recordati Rare Diseases Inc.
New York, New York, United States
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Shauna O'Donnell is a highly experienced clinical project manager with over 10 years of clinical study management experience. She has worked in Oncology on diagnostic/IVD and Immunotherapy studies, leading a global oncolytic virus trial for a small immunotherapy biotech. Shauna is known for her self-starting nature and thrives in fast-paced, collaborative environments. She possesses skills in project management, research regulations, and FDA regulations. Shauna has worked at GRAIL and the University of California San Francisco, gaining valuable experience in clinical trial start-up and operations.
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Emails and Phone Numbers

@ucsf.edu
@gmail.com
@grailbio.com
@gmail.com
@recordatirarediseases.com
+1 732272****
+1 495225****
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About

A clinical project manager with over 10 years of clinical study management experience. I have worked primarily in Oncology on diagnostic/IVD as well as Immunotherapy studies. I currently lead a global oncolytic virus trial for a small immunotherapy biotech. I am a self-starter who thrives in fast-paced, collaborative, team-oriented environments. Skills and specialties: Project management, working knowledge of relevant research regulations including ICH E6 (GCP) and FDA regulations (21 CFR Part 11, 21 CFR Part 50, 21 CFR Part 312, 21 CFR Part 312,) clinical trial start-up and operations, study budget creation and maintenance, protocol development, enterprise system implementation, eCRF creation, data management, EDC, CTMS, TMF, results reporting, event planning, public speaking, social media.

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Work Experience

440 Route 22 E, Bridgewater, New Jersey, 08807, US

Pharmaceutical Manufacturing

211
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Shauna O'Donnell's Professional Milestones

  • Clinical Trial Associate (2016-09-01~2017-10-01): Successfully managed and executed complex clinical trials, ensuring the successful completion of multiple patient outcomes.
  • Clinical Development Project Associate (2017-10-01~2018-03-01): Driving clinical innovation and paving the way for a breakthrough in healthcare delivery.
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Education

University of Pennsylvania
University of Pennsylvania

Environmental Studies (policy Concentration)

1136073600-1262304000
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