Shounak Damle
Let\'s achieve excellence together
- Role
- Manager, Clinical Operations at IQVIA
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Shounak Damle
As the Director of Customer Success at CLIN STREET, I contribute to ensure our eClinical solutions such as electronic trial master files (eTMF), CTMS, eFeasibility, etc are having best in class features making life of industry collaborators easy, simple and meaningful! With over 13 years of experience in various aspects of eTMF, from manufacturing to shipping, lab studies, clinical trials, and publishing, I offer a wide range of expertise that adds value to our organization and our customers.My core competencies include operations management, account management, business analysis, and knowledge contribution. I am a TMF Zone Expert and a Knowledge Contributor at the TMF Reference Model, where I share best practices and insights on eTMF management and standards. My mission is to help our clients achieve the full potential of their eTMF and other eClinical solutions to enhance their compliance, and optimize their outcomes. I am passionate about driving excellence and innovation at CLIN STREET and beyond.
Experience
Manager, Clinical Operations
Sep 2024 — Present
Education
Mitcon
PG Diploma - Clinical Research and Clinical data management, Clinical Research
2011 — 2012
Sikkim Manipal University - Distance Education
Master of Business Administration (M.B.A.), Management Information Systems, General
2011 — 2013
Dr.D.Y. Patil Institute Of Pharmacy
Bachelor's Degree, Pharmaceutics, Medicinal chemistry,Pharmacology,Pharmaceutical analysis
2005 — 2009
Savitribai Phule Pune University
Bachelor, Pharmacy
2005 — 2009
Skills
- Teamwork
- Ich-Gcp
- Quality Management
- Fda
- Change Management
- Time Management
- People Management
- Decision Making
- Problem Solving
- Analytical Approach
- Java
- Project Planning
- Microsoft Office
- Gmp
- Quality Assurance
- Management
- Validation
- 21 Cfr Part 11
- Uat & Migration Testing
- Automation
- Clinical Trials
- Standard Operating Procedure (Sop)
- Good Clinical Practice (Gcp)
- Leadership
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