
Mha Megan Manion Ccrp
Dedicated female professional with experience in multiple health care settings; including academic research, early-to-late phase oncology, administrative clinical... | Carmel, Indiana, United States
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Mha Megan Manion Ccrp’s Emails me****@ro****.com
Mha Megan Manion Ccrp’s Phone Numbers No phone number available.
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Mha Megan Manion Ccrp’s Location Carmel, Indiana, United States
Mha Megan Manion Ccrp’s Expertise Dedicated female professional with experience in multiple health care settings; including academic research, early-to-late phase oncology, administrative clinical organizations, project management, pharmaceutical, and the diagnostic industry. I excel in a team setting as well as executing as an individual contributor. My areas of interest include health care administration within informatics, research development, and the advancement of diagnostic tools in the health care industry. I entered the health care world, highly interested in behavioral research. However, I quickly became passionate about the future of medicine. This lead me to pursue a fulfilling career path in Clinical Research. While working for the IU School of Medicine, I spent a few years in all areas of oncology clinical research trials, with roles focused in phase I-IV trials; however, my general clinical focus and interest lies in early phase. Here, I also gained valuable experience in regulatory documentation and scientific review committee submissions. I then moved into global project management at Covance where I expanded my knowledge across several different roles working for one of the largest central laboratories in the US. After leaving the central laboratory space, I had the exciting opportunity to join Roche Diagnostics; first as a senior project manager supporting Roche Sponsored Study protocols. I have most enjoyed dedicating my professional life to compliant and efficient research! In regulatory affairs, I've supported the Clinical Chemistry & Toxicology portfolio; including support of existing analytical systems, application of existing assays to new systems & introduction of new analytical solutions, software and systems. Work to execute agile principles cross customer area. Globally lead, Class C, De Novo, and PMAs and breakthrough device designations. Most recently, I'm supporting companion diagnostic projects (development of submission and ensuring that clinical trials as designed meet regulatory requirements for product clearance in both the US and EU). Society of Clinical Research Associates Member and Certified Clinical Research Professional (CCRP), Member ID: 49166 Extracurricular activities: Global Quality and Regulatory FLEX Program Manager, Keep Indianapolis Beautiful, Junior Achievement Job Spark, Roche IU alumni recruiting volunteer (IU College of Arts & Sciences)
Mha Megan Manion Ccrp’s Current Industry Roche
Mha
Megan Manion Ccrp’s Prior Industry
Indiana University School Of Medicine
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Covance
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Roche
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Work Experience

Roche
Project Leader- Phcs
Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Roche
Senior Regulatory Affairs Manager
Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Roche
Regulatory Affairs Manager
Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Roche
Regulatory Affairs Consultant
Wed Apr 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Roche
Sr. Project Manager- Medical And Scientific Affairs
Mon May 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Covance
Portfolio Manager
Sun May 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon May 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Covance
Global Study Manager Ii
Sun Nov 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Covance
Global Study Manager I
Sun Feb 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Nov 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Covance
Project Manager
Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Feb 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Indiana University School Of Medicine
Clinical Research Specialist
Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Indiana University School Of Medicine
Clinical Data Coordinator
Mon Oct 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Indiana University School Of Medicine
Oncology Clinical Assistant
Wed Jun 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Oct 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Indiana University School Of Medicine
Student Intern
Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)