Prathamesh Mungekar

Seasoned CDM leader with 19+ years driving global clinical trials across Veeva Vault, Medidata Rave, Oracle Clinical, and Inform. Expert in database design, SAS/R programming, and regulatory compliance. Proven track record mentoring teams and delivering quality at scale.

Group Leader / SME - TCS

(2014-12)

• Lead SME for Veeva Vault and Medidata Rave across global clinical trial portfolios, ensuring end-to-end quality compliance
• Directed database design teams, owned DMW project launches, and led technical data transfers across multiple CDMS platforms
• Delivered RFP reviews, resource forecasts, and developer training programs aligned with evolving CDMS market standards

Lead CDM Programmer - Inventive Health

(2011-04 - 2014-12)

• Designed CRFs and databases from study protocols; drove peer QC processes to maintain high-quality CDM deliverables
• Mentored new associates, accelerating onboarding and raising team technical competency across CDM applications
• Led process optimization initiatives and provided risk communication in client forums, improving delivery efficiency

Senior Clinical Programming Analyst / Trainer - PAREXEL International

(2009-03 - 2011-04)

• Designed and validated databases in OC-RDC and Inform Central Designer for global regulatory-compliant studies
• Delivered SAS QC extracts and managed batch data transfers, maintaining global libraries across multi-site trials
• Trained and mentored associates on technical and functional project aspects, building departmental capability

Biometrician (Study Startup) - SIRO Clin-Pharm Pvt Ltd

(2007-01 - 2009-03)

• Built Oracle Clinical databases, PL/SQL procedures, and edit checks supporting study startup and Six Sigma process improvements

Post Graduate Diploma - Data Science - IIIT Bangalore (2022)

Bachelor of Science - Computer Science (2006)