Pronoy Chowdhury

About Pronoy Chowdhury

Clinical Research Professional:Medical Writing | Clinical Trial Data Disclosure and Transparency | Project Management | EMA 0070 Policy | Health Canada | Lay Summary Writing | PharmaCM | Veeva Vault | Data Anonymisation and RedactionClinical Trial Transparency Specialist with over 9.5 years of industry experience. Furthermore, I have exposure to other regulatory documents (Patient Safety Narratives, Informed Consent Form etc) and project management. Presently working with GlaxoSmithKline as Manager, Clinical Trial Transparency.Stand-up Comedian:Over 5 years of experience as standup comedian| Performed in more than shows (online and offline)| Managed to entertain crowds ranging from 25-500 | Performed with the best in the industry (Harsh Gujral, Jeeveshu, Gaurav Gupta, Vijay Yadav, Rajat Chauhan, Jaspreet Singh, Nishant Tanwar, Kaneez Surka, Sorabh Pant, Abijit Ganguly, Angad Singh Ranyal etc to name a few)| YouTube video available: https://youtu.be/F-3HrzCw0C0Clientele includes: State Bank Of India, Cowrks, Coworks, RMZ, 2GETHR, Wework, Shell, Stay Abode, 91SPRINGBOARD, Coho, Radio Mirchi, Increff, Everbridge etc.You can reach out for corporate shows via email : c•••••••@gmail.com or DM me on Instagram:@pronoy_chow.

Experience

1. Manager Clinical Trial Transparency

   GSK

   Feb 2023 — Present · Bengaluru, IN

   1.Drive end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing. Serve as a single-point of contact for project teams and functional matrix teams for questions related to Data Disclosure.3. Assess studies for disclosure and patient level data sharing requirements and guide study teams through the achievement of complete, consistent and timely disclosure and listing of studies in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register and Data sharing websites (such as Clinical Study Data Request (CSDR)).4. Collaborate with a team of recognized subject matter. Work with outsourced resources (platforms, consultant, capabilities).5.Supervise and monitor delivery of the documents amongst the different Service providers involved.6. Coordinate workload distribution and establish/ maintain a robust communication interface across all people involved in the delivery of the documents. Act as primary point of contact for service provider(s). Monitor CRO performance. Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into GSK’s strategy. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements. Proactively identify business transparency risks and propose and implement strategies to manage the implications of these risks on the business.13. Contribute to the development of training material for the business, clinical support services and service provider(s).14. Develop and maintain knowledge and expertise in Data Disclosure environment (Publications and Data Disclosure).

Education

• Don Bosco School Guwahati

  Tenth standard

  1998 — 2008

• Aristogene Biosciences

  Microbiology and Immunology

  2012 — 2013

• Shrimanta Shankar Academy

  Twelfth Standard, Science

  2008 — 2010

• M.S. Ramaiah College Of Arts Science And Commerce

  Bachelor of Science (B.Sc.), Genetics/Microbiology/Biochemistry

  2010 — 2013

• Dayanandasagar College Of Science Arts and Commerce

  Master's degree, Microbiological Sciences and Immunology

  2013 — 2015

Skills

• Good Clinical Practice (Gcp)
• Microsoft Office
• Food Microbiology
• Environmental Microbiology
• Cell Culture
• Trial Master File
• Clinical Trials
• Research
• Neurology Clinical Research
• Clinical Site Monitoring
• Biotechnology
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Laboratory
• Medical Microbiology
• Life Sciences
• Biochemistry
• Immunology
• Pcr
• Molecular Biology
• Oncology Clinical Research
• Microsoft Word
• Powerpoint
• Microsoft Excel
• Medical Writing
• Etmf
• Interventional Cardiology
• Clinical Microbiology
• Clinical Research
• Electronic Data Capture (Edc)
• Gmp
• Microbiology