Dr. Prayag N. Shah [Md, Mba] Pharma And Biopharma Clinical Development Expert Email & Phone Number

• Ensures that global clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards• Provide strategic and managerial oversight of all clinical trial projects from early to late phase project specific activities• Responsible for organizing and implementing operational strategies for product specific global clinical development• Prepare required regulatory documents, such as annual reports, updating of IB, and review of final study reports as per applicable regulatory requirement• Key role in reviewing and finalizing protocol and other key study documents• Identifies KOL (Key Opinion Leaders) in related therapeutic areas and establishes relationships and collaboration as appropriate• Serve as sponsor medical monitor for all clinical trial projects and if required, for other patient centric projects• Lead role in developing, finalizing & executing safety management plan• Conduct clinical feasibility of the assigned protocol by identifying appropriate investigators• Provide appropriate therapeutic disease & protocol specific training to entire clinical operation and project management team to perform job duties.• Negotiate budgets with investigator sites, assist site in finalization and sign-off the financial contract.• Due diligence of third party vendors• Ensure that adverse events are identified, reported within specified timelines to all appropriate parties, appropriate compensation to the subjects as recommended by the EC & approved by local applicable regulatory agency • Ensure protocol compliance in terms of conduct, documentation and timelines by providing active oversight through review of all core documents• Works closely with biostatistics to interpret and analyze clinical trial results and outcomes• Conduct project specific training for the entire team before trial commences and supports the team by effectively addressing the issues on an ongoing basis.

Listed skills include Videography, Music Remix, Interpersonal Skill, Communication, and 1 others.