Anant Jain
Manager Clinical data Management
Summary
Results-driven Clinical Data Management leader with over 13 years of progressive experience in the life sciences industry, specializing in end-to-end clinical data management operations. Proven expertise in Veeva study design , CRF finalization, database build/testing, and regulatory compliance. Strong track record in leading global clinical trials, aligning data deliverables with business and regulatory objectives, and optimizing EDC systems including RAVE, INFORM, and VEEVA . Experienced in Agile methodologies and Scrum frameworks , with hands-on use of JIRA for sprint planning. Recognized for fostering cross-functional collaboration, enhancing data quality through continuous improvement, and leveraging technical acumen with leadership skills to deliver operational excellence and high-quality, inspection-ready data.
Overview
14
14
years of professional experience
2
2
Languages
Work History
Manager (Clinical Data Management)
Tata Consultancy Services
05.2020 - Current
- Team Leadership: Leading a team of CDM professionals across multiple clinical trials. Assigning tasks, monitoring progress, conducting performance evaluations, and driving training and development initiatives.
- Individual Study Handling: Independently managing end-to-end clinical studies, including CRF finalization, database design/testing, query handling, SAE/lab reconciliation, and data cleaning through to database lock.
- Stakeholder Collaboration: Acting as a central point of contact for internal teams and external stakeholders, ensuring smooth execution of data management deliverables and adherence to timelines.
- Performance & Resource Management: Allocating resources, tracking productivity, and aligning deliverables with organizational goals.
- Process Improvement: Spearheading initiatives to enhance SOPs and improve data quality and operational efficiency.
- Recruitment & Onboarding: Actively involved in hiring, interviewing, onboarding, and mentoring new team members.
- Driving end-to-end clinical data strategy and oversight, ensuring consistency across EDC systems (RAVE, VEEVA) and third-party vendors
- Leading sprint-based execution of DM tasks, including backlog grooming and sprint reviews using JIRA Agile boards.
- Facilitating daily Scrum meetings and cross-functional syncs with Biostats, Medical, and Clinical Ops
- Managing data ingestion, cleaning, discrepancy resolution, and interim/final database locks
Senior Clinical Data Associate
Syneos Health
05.2018 - 04.2020
- Served as Lead CDA and backup Project Data Manager for assigned studies.
- Managed study start-up activities including CRF annotation, DB setup, edit checks, and UAT.
- Handled ongoing data management tasks – query resolution, data review, SAE/lab reconciliation, SAS listings checks.
- Coordinated with clients and internal teams for study updates, issue resolution, and lock planning.
Senior Clinical Data Coordinator
IQVIA
12.2015 - 05.2018
- Led CDM operations for small- to mid-sized trials; backed up Data Team Lead.
- Reviewed data, resolved queries, and ensured consistency across listings.
- Managed start-up and close-out activities including RECIST reviews for oncology studies.
- Collaborated with programming and clinical teams for post-production DB changes.
Senior Process Associate
Cognizant India Pvt. Ltd.
05.2014 - 12.2015
- Performed quality checks for third-party data and SAE reconciliation.
- Generated QC reports and tracked issues for timely resolution.
- Led CAPA, RCA discussions and supported client audits.
- Provided feedback and mentoring for improved team accuracy.
Clinical Data Analyst
Accenture Pvt. Ltd
02.2012 - 05.2014
- Conducted data validation using Inform platform.
- Performed query management, coding checks, and external data reconciliation.
- Supported clean patient delivery, coding review, and study closeout.
- Mentored junior staff and interacted with onshore teams for issue resolution.
Education
M.Sc. - Biotechnology
T. John College, Bangalore University
06.2011
B.Sc. - Biotechnology
JECRC College, University of Rajasthan
06.2009
Skills
EDC Platforms:- Inform, Oracle RDC, Target Health, Medidata Rave, Veeva Vault
Interests
Cooking, Gardening, Traveling
Qualities
Strategic thinker with hands-on execution capabilities, Strong leadership, client-facing, and mentoring skills High attention to detail and compliance adherence Adaptable to fast-paced environments with tight timelines Skilled in time management, multitasking, and cross-functional collaboration
Timeline
Manager (Clinical Data Management)
Tata Consultancy Services
05.2020 - Current
Senior Clinical Data Associate
Syneos Health
05.2018 - 04.2020
Senior Clinical Data Coordinator
IQVIA
12.2015 - 05.2018
Senior Process Associate
Cognizant India Pvt. Ltd.
05.2014 - 12.2015
Clinical Data Analyst
Accenture Pvt. Ltd
02.2012 - 05.2014
B.Sc. - Biotechnology
JECRC College, University of Rajasthan
M.Sc. - Biotechnology
T. John College, Bangalore University
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