Shauna O'Donnell
University of Pennsylvania
Tell me more about Shauna O'Donnell?
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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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.
...See MoreWork Experience
innovative clinical leader with a passion for improving human health
Pharmaceutical Manufacturing
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.
Education
Environmental Studies (policy Concentration)
1136073600-1262304000Skill
Community Outreach
Research
Event Planning
Public Speaking
Social Media
Data Analysis
Microsoft Office
Project Management
Powerpoint
Gis
Horticulture
Microsoft Excel
Fundraising
Non Profits
Program Management
Sustainability
Editing
Event Management
Operations Research
Sports Coaching
Rowing
Environmental Awareness
Project Planning
Management
Marketing
Good Clinical Practice
Clinical Research
Standard Operating Procedure
Clinical Trials
Gis Analysis
Policy Analysis
Leadership
Analysis
Customer Service
Microsoft Word
Time Management
Clinical Data Management
U.s. Food And Drug Administration
Quality Assurance
Life Sciences
Code Of Federal Regulations
Sop Development
Certification
Colleagues
Becky Z.
Vice President Human Resources
Michael Waters
President | General Manager North America
Zbigniew Glomski
General Manager | Chief Executive Officer
William Ludlam
Chief Medical Officer | Vice President Clinical Development
Michael HU
general manager recordati rare diseases china
Other Named Shauna O'Donnell
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Shauna O'Donnell works for Recordati Rare Diseases Inc.
Shauna O'Donnell's role in Recordati Rare Diseases Inc. is innovative clinical leader with a passion for improving human health
Shauna O'Donnell works in the industry of Pharmaceutical Manufacturing
Shauna O'Donnell's colleagues are Becky Z.,Michael Waters,Zbigniew Glomski
Shauna O'Donnell's latest job experience is innovative clinical leader with a passion for improving human health at Recordati Rare Diseases Inc.
Shauna O'Donnell's latest education in University of Pennsylvania