Bharat Vaishnav Email and Phone Number

• More than 15 years of experience in Life science domain having expertise in managing Data Management projects and clinical studies• More than 8 years of experience in team management• Accountable for delivery of clinical studies at TCS• Expertise in handling Oncology clinical trials and transition process• Trained on Agile methodologies and it's implementation process• Good exposure in budget forecasting and management• Expertise in handling big team and complex trials.• Society for Clinical Data Management (SCDM) Certified Clinical Data Manager (CCDM®), (Certification Number – 25813)• Completed Medidata Rave® Certified Study Builder Examination (Registered ID# MDSO128740020210)• Awarded by Basic Lean Certification for automating third part checks for project• Workes as Project Data Manager Expert (PDME) to provide industry expertise and quality assurance for project delivery teams.• Completed automation of Imaging (RECIST scan) checks.• Extensive knowledge of Medidata RAVE• Expertise in handling WBDC and Paper studies• Extensive knowledge in set up, conduct and close out of clinical studies• Experienced in creating study documents like Rave build specification, eCRF specification, Visit Matrix, Data Management Plan, eCRF review manual, eCRF instructions and Data validation checks• Experienced in Rave architect and developer role to build clinical studies• Worked on various therapeutic area like Oncology, Neuroscience, Infection and Cardiovascular• Expertise in IT skills with years of experience working on MS-Office, MS-Project, MS-Outlook and in general knowledge of Clinical SAS domain