Company

Product Head, TCS ADDTM MDR

Personal Information

Mayank has more than 20 years of experience in Clinical domain & Currently working as Product Head for TCS ADD Metadata Repository repository(MDR) product in TCS.

His expertise span across building products, leading cross functional teams, bringing operational excellence and driving change for transformational programs. Successfully led and delivered many large scale and highly critical transformational programs. He holds a Bachelor degree in Computer Science & is PMP certified professional.

Company

Sr. Director Operations RDS, IQVIA

Personal Information

• Sujit has over 20 years of experience within pharma services
• His journey has been through global delivery, eClinical operations and operational excellence
• He has worked with top Pharma companies and ITES service organizations across Clinical Operations, Data management and Data transformation
• He has managed teams across all phases of clinical trials and multiple therapeutic areas
• He has a 10 Yr. old Son, and enjoys photography and sports during his free time
• At present, Sujit is Sr. Director Operations with IQVIA RDS

Company

Director-Data Management Head India, Johnson & Johnson

Personal Information

Sreesha Nair presently holds the position of Director, Data Management Head India at Johnson & Johnson. She has over 18 years of experience in Clinical Data Management and has played multiple leadership roles. She has led and implemented strategic, people and technical initiatives in her previous endeavors. She’s passionate about learning the science behind drug discovery and people development.

She has done her master’s in microbiology and is a certified scrum master. She has also earned a certification in Cancer Genomics and Precision Oncology from Harvard Medical School online learning.

Company

Program Lead, Pfizer

Personal Information

Agatha Christina Moses has over 19 years of IT and pharmaceutical industry experience. Her experience spans Clinical database programming, Computer system validation, Clinical reporting and data analytics, and R&D Application Maintenance. She is a Program Lead at Pfizer, leading a multifunction portfolio that embraces Reporting and Data Analytics, User Acceptance Testing, Medical Technology, Process & Training and Business operations. She provides strategic and operational leadership insights and oversees the delivery of the portfolio.

She drives continuous process enhancement and innovation by connecting clinical trial processes and technology to improve quality and efficiency. She has led and contributed to numerous initiatives and automation projects. She holds a Master of Technology degree in Computer Science. She is an active member SCDM India Membership Committee.

Company

Manager, Clinical Data Management, ICON

Personal Information

Zakir Mohammed is a post-graduate in Biotechnology and comes with an industry experience of 17 years. He has worked with multiple CROs including IQVIA and Labcorp in the past, he is currently leading a FSP with ICON and based out at Bangalore, India. He has been passionate about speaking in multiple Clinical research conferences and programs.

His expertise in the clinical data management is being highly valued. During his tenure he has served many prestigious clients and has been an expert in terms of setting up Data management teams and delivering the FSP model studies on an ongoing basis. In his free time he loves teaching and has been teaching the underprivileged for past 18 years, this has motivated him to secure and additional B.Ed qualification in the year 2020.

Company

Sr.CDA, Data Science, Syneos Health

Personal Information

Mausami Bhatt is a Clinical Data Scientist with a decade of successful experience in Clinical Data Science. She is a versed Project manager with a demonstrated history of working in the hospital & health care industry. Learning never ends is her strength and she works towards the improvement by attaining discrete certifications like CCDM,PMP. A strong believer in the power of positive thinking in the workplace, she regularly contributes on fun filled internal events to assist employees with effective engagement activities with her larger team. Associating with noble causes like vaccination awareness programs, adult education she also works towards contributing back to the society.

Company

Persistent Systems

Personal Information

Total 18+ Years of experience in clinical domain.   10+ years of experience in working with CDISC standards (CDASH, SDTM, ODM-XML, Define-XML).  I have led or been part of various initiatives such as process improvement in SDTM delivery, LOINC implementation, Re-screening logic harmonization at organization level, Receiving EDC and 3rd Party data in ODM model and Managing Clinical Metadata.

Company

Director – Global Clinical Programming & Analytics, Fortrea

Personal Information

Result oriented leader with proven industry experience of 17+ years in CRO and IT industry. Leading diversified global team across the regions with various technologies in programming, analytics, testing and reporting teams. Proven expertise in managing end to end global data management activities starting from protocol till DB closure with various technical teams in Functional Management, Process improvements, Risk Analysis & Mitigation plan, Customer Relationships, Process Designing & Project Management areas by implementing revolutionary solutions.

Demonstrated exceptional leadership and an unwavering commitment to ethical and evidence-based practices. Exceptional attention to detail, analytical skills, and ability to collaborate with diverse teams. Easily adaptable to evolving industry trends, and drive innovation in the clinical trials to bring in efficiencies to inspire and drive positive change in the teams. Expertise in achieving sustainable, long-term efficiencies by working with the teams and improving the processes.

Company

Associate Director, Clinical Data Standards, Novartis

Personal Information

Dhananjay Thakur is a Chemistry graduate with overall 20+ years of experience, which includes 7+ years of experience as an Editor in Medical Transcription and 13 years of experience in Clinical Research industry. He is currently working with Novartis as Associate Director, Clinical Data Standards. He is passionate about implementation of Standards in his day-to-day activities. In his current role he works as an SME involving in activities like content approval, defining processes, supporting cross functional teams with day-to-day challenges, etc.
He volunteers for CDISC initiatives like CDISC Lab Controlled Terminology Team, CDISC CT User Guide team, and earlier participation in CDISC CORE.

In past, he has worked with Tata Consultancy Services across different roles like Data Manager, Lead, Data Manager, SDTM Mapper, SDTM Team Lead, etc. and performed various activities in different Therapeutic areas.

Company

Deputy General Manager, Life Science Digital Operations, Cognizant

Personal Information

Hetal Chheda is a Clinical Data Management professional having rich 18+ years of experience in delivering and managing end-to-end Clinical Data Management for global clinical trials across various Therapeutic areas and phases.  She is a CDM professional with proven track record of successful project management and producing quality outcomes through leadership and team motivation. She holds extensive experience in developing and executing solutions to address business needs by providing high quality, cost-effective services that support the organizations business strategies and have demonstrated success managing global operations and delivering results within SLAs in
complex environments.

She possesses strong understanding on the overall Clinical trial process including transition, audit, inspection, quality control and end to end project management. She is a certified PMP with several years of experience in leading DM teams for major pharmaceutical clients across the globe from onsite and offshore. With the current position of Engagement Delivery lead within Cognizant Life Science Intuitive Operations and Automation team, she is overseeing the delivery and portfolio management for the leading Pharma CDM accounts with 100+ member team. She is also a domain SME for CDM and contributes to CDM training material, internal upskilling courses, inputs to CDM automations etc.