Rajesh Krishnan

About Rajesh Krishnan

I am a highly accomplished techno-functional professional with extensive experience in Life Sciences and Healthcare IT industry. I have in-depth knowledge and hands-on experience in R&D with pronounced exposure in the clinical development space. I am adept in handling client business development, business analysis, program management, solution development and Go-to-Market initiatives.I have worked in SDTM submission data conversion projects in 100\'s of clinical trials across different phases and therapeutic areas. My specialties includes – CDISC – SDTM/ADaM submission standards - worked on almost 150 studies as data analyst and business analyst clinical application area like CDMS/CTMS/EDC, Medical coding tools for clinical trials, Investigator Portal GxP and 21 CFR part 11 compliant - Computer system validation (CSV) using GAMP 5 approach in category 3/4/5 applications like Global Event Management System (Adverse Event) for devices, AutoDesk (PLM), Learning Management System (SAP) and Documentum, Risk Based Monitoring platformTrained in Argus Safety System. Life Sciences Data Hub, Veeva Content management systemI am also passionate in expanding my interest areas that include - Real World Evidence – Health Economics Outcomes Research, secondary market research on orphan diseases.

Experience

1. Associate General Manager

   HCLTech

   Mar 2025 — Present

Education

• Tamil Nadu Doctor M.G.R. Medical University

  B.Pharm, Pharmacy

• Tamil Nadu Doctor M.G.R. Medical University

  M.Pharm, Pharmacognosy

• Fairleigh Dickinson University

  MS, Pharmaceutical Chemistry

  2003 — 2005

• The University of Texas at Austin

  Post Grduate Program in AI for Leaders, Artificial Intelligence

• Indian Institute of Management, Calcutta

  EPBM, Business Administration and Management, General

  2013 — 2014

Skills

• Requirements Analysis
• Validation
• Argus Safety
• Management
• Quality Assurance
• Life Sciences
• Business Analysis
• Verification and Validation (V&V)
• Data Analysis
• Pharmacovigilance
• Software Documentation
• Sdlc
• Validation Master Plan
• Iq Oq Pq Protocols
• 21 Cfr Part 11
• Risk Based Monitoring
• Team Management
• Cdisc
• Clinical Data Management
• Pharmaceutical Industry
• Sop
• Sdtm
• Regulatory Affairs
• Lifesciences
• Validation Summary Report
• Clinical Trials
• Pharmaceutics
• Clinical Development