Company

Head Data Monitoring and Management, Pfizer Healthcare India Pvt. Ltd.

Personal Information

Rajesh Kunhandy is India Head of Data Monitoring and Management at Pfizer. Rajesh brings 28+ years of industry experience. Rajesh’s career journey began with several years of hands-on experience as a clinical data manager, where he gained a deep understanding of data collection, validation, and analysis processes. This foundation allowed him to progress to more strategic roles, ultimately leading to his current position as the head of the Clinical Data Management division at Pfizer. In his earlier roles Rajesh has provided stellar leadership to establish and scale up data management operations at global pharma and clinical research organizations.

Rajesh has a proven track record of building high performing teams and spearheading multiple cross functional initiatives encompassing process improvements, policy development, change management & vendor management to accomplish business goals & further the organizational vision. Rajesh’s collaborative approach extends to cross-functional teams, including clinical operations and biostatistics. His leadership has established him as a respected figure in the field, making him an integral part of Pfizer’s mission to bring life-changing therapies to patients worldwide.

Company

Director – Clinical Data Standards, Novartis

Personal Information

Tushar Sakpal is Director – Clinical Data Standards – Novartis . He is currently responsible for end to end global clinical standards management including, data acquisition (CRFs & non CRFs), eDC build, edit checks, SDTM, ADaM, TFL and other global metadata concepts. He also represents Novartis in global forums and consortiums discussing standards and automation related strategies.

Tushar brings in 22 years of Clinical Development expertise with prior experience in TCS, PharmaNet (now Syneos), Pfizer, GE Capital, Reliance Life Sciences and Siro ClinPharm. Prior to joining Novartis, he worked with TCS for 9.5 years in delivering Biostatistics and Statistical Programming services across global Pharma. Also, he was closely involved with the technology team for developing platforms / tools for clinical domain in Data Management, Statistical Programing and Biostatistics space, which included MDR based platform for storing global metadata and SDTM transformations. He has good understanding of CDISC guidelines, Policy 70 requirements, eSubmission
package requirement, EudraCT / CT.Gov requirements.

Company

Head, Clinical Services-Digital Medicine and Medical Technologies, Tata Consultancy Services

Personal Information

Jasmin Johnson heads Clinical and Safety Services at TCS.

Jasmin has worked on clinical and experimental R&D in hospital, pharmaceutical and research organization, and technology companies. She has published papers on clinical research in tuberculosis, use of technology for disease surveillance, laboratory management, and on clinical trials of medicines. She did her MD in Microbiology from BJ Medical College and led research initiatives on multi-drug resistant
tuberculosis in a multicentric clinical trial sponsored by INCLEN/USAID.

Thereafter, she worked on drug discovery and development in Indian Pharma. In the course, she set up an experimental pharmacology laboratory and several models for efficacy studies, and conducted multicentric clinical studies. For more than 17 years, Jasmin has been leading various sponsor partnerships in FSP models for Clinical data management and has contributed to significant transformations within clinical research and safety. She has 25 years of clinical experience, is an Agile coach, and a TCS workplace coach.

As part of her contribution to society, Jasmin has written a book titled, “Her Passover : Story of Menopause, Anger & Love”.