Ratin Sharma
Thane (Mumbai)
Summary
A skilled Clinical Research Professional with 14+ years of recognized industry experience in various roles, adept at effectively handling multiple responsibilities. I possess a strong understanding of the eTMF domain, having collaborated with diverse clients and worked with multiple eTMF document types. My experience in global environments and assignments to various client locations has provided me with valuable insights and enabled me to successfully meet client requirements.
In India, I successfully led a large eTMF team of over 25 members, managing all operational responsibilities. This role significantly enhanced my leadership skills and domain expertise.
Currently, I am working as an Automation Program Manager at TCS, where I manage pharmaceutical client automation projects (VBA/Power Applications, Power BI) in alignment with the agreed Automation Governance Framework.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Program Manager
TATA Consultancy Service (TCS)
Mumbai
01.2023 - Current
- As a Program Manager at TATA Consultancy Service (TCS), I was responsible for overseeing multiple automation projects and ensuring their successful execution
- I worked closely with cross-functional teams, including clients and stakeholders, to define project scope, timelines, and deliverables
- My strong leadership skills and project management experience allowed me to consistently deliver projects on time and within budget.
- Managed multiple automation projects simultaneously
- Collaborated with cross-functional teams
- Defined project scope, timelines, and deliverables
- Consistently delivered projects on time and within budget
Project Manager
TATA Consultancy Service (TCS)
Mumbai
07.2021 - 12.2022
- Project Transition
- Project Management
- Time Management
- Leadership
- Automation
Assistant Manager - ETMF Operations
TATA Consultancy Service (TCS)
Mumbai
04.2017 - 06.2021
- Overall in-charge of day-to-day activities of the process
- Ensure adequate resources for the project throughout its lifecycle
- Ensure appropriate distribution of work within the team
- Participate and conduct team meetings
- Provide annual performance appraisals and regular feedback to associates
- Leave, resignation, and access management
- Monitor and track project-specific KPIs
- Coordinate and communicate effectively with internal and external stakeholders
- Manage and report activities to the management
- Contribute to Process Improvements
- Identify and resolve internal and external issues
- Participate in the recruitment and interview process
Sr. Regulatory Records Specialist - eTMF
INC Research (Syneos Health)
Gurgaon
05.2014 - 03.2017
- Monitoring and accordingly prioritizing daily workflow for the Document Control Specialist team; imparting assistance on monitoring productivity and quality of department outputs functions including resourcing to accommodate ongoing workflow
- Mentoring and training junior team members in functional areas of expertise; working closely with functional team management to ensure deliverables by relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs)
- Creating and maintaining document repository; undertaking scanning and indexing for all site-related documents; receiving inventory, routes, and maintaining applicable project documents {e.g., Case Report Forms (CRFs), Data Clarification Forms (DCFs), data management files, clinical documents, and clinical files as well as project-specific regulatory documents}
- Ensuring security and compliance of all documents related to active and archived projects
- Confirming that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room
- Working on-site closure, preparing subject files, drafting inventory, and reconciling files to listings provided by clients/leads Data Manager/Project Team Lead; ships files to the client and or off-site storage
Team Lead - eTMF (Records and Information Management)
Syntel Inc.
Pune
06.2013 - 04.2014
- Led multiple documents management teams offering clinical research documents management services to clients delivering high-quality TMF documentation in stipulated timelines
- Ensured delivery of relevant training on e-TMF to the team as per the requirement of the project; liaised on workload and managed staff accordingly
- Managed work allocation to team members and tracked the performance/progress in terms of productivity and quality on a daily/weekly basis; attended periodic teleconferences with clients and addressed any study related issues or concerns; communicated the same to the team
- Participated in regulatory and sponsor audits as and when required; identified and implemented opportunities for process improvement and optimization
- Ensured compliance of eTMF teams with ICH/GCP regulations, guidance documents and SOPs
- Undertook activities related to leave management; resignations/absconder communication to the operations manager
Clinical Trial Administrator (eTMF) - Resource Operations
Phlexglobal Ltd.
Amersham
07.2011 - 01.2013
- Undertook pre-audit / inspection (MHRA) review of TMF at NHS or client site; performed tasks related to eTMF Management, Remap, QC, eTrans, Indexing, Image Quality/Process Quality using Input Accel of Client's Clinical Documentation
- Ensured eTMF work comply according to ICH/GCP regulations, documents guidelines, and SOPs, and updated the project status to the Operation Manager accordingly
- Worked with the CLRN Industry manager to identify solutions concerning R & D submission
- Led on processes within the KHP-CTO (Kings Health Partners - Clinical Trials Office) to assess capacity and feasibility for conducting specific commercial clinical trials at King's Health Partners and across the L(S)CLRN (South London Comprehensive Local Research Network)
Hospital Pharmacist
Shashi Nursing Home
Indore
10.2007 - 11.2008
Sales Executive
Shreya Life Science Pvt. Ltd
Bangalore
12.2006 - 09.2007
Education
Doctorate in Management Studies -
Indian Institute of Business Management and Studies (IIBMS)
Mumbai, India01.2017
Master in Pharmacology -
University of Hertfordshire
Hatfield, United Kingdom01.2010
Bachelor of Pharmacy (B.Pharm) -
Rajiv Gandhi University of Health Sciences
Bangalore, India01.2007
Skills
- Project Management
- Problem-Solving
- Organizational Skills
- Team Management
- Process Improvement
- Risk Assessment
- Program Management
- Automation Governance
- Clinical Operations
- eTMF Operations
Awards
- BPS Champions League - TCS
- Special Achievement Award - TCS
Personal Information
Nationality: Indian
Certification
Project Management for Managers from IIT Roorkee
Year - 2024
Generative AI Overview for Project Managers from Project Management Institute (PMI)
Year - 2023
The Basics of Scrum from Project Management Institute (PMI)
Year - 2023
Manage Project Effectively from Effective Project Management Academy
Year - 2021
Remote Work and Virtual Collaboration Professional Certificate from CertiProf International
Year - 2021
Advanced Certification In Clinical Research Methodology from Indian Institute Of Business Management And Studies
Year - 2020
Scrum Foundation Professional Certificate from CertiProf International
Year - 2020
Clinical - Professional Development Program (C-PDP) from PharmaLex - formely Phlexglobal
Year - 2013
Introduction to Clinical Research and GCP from PharmaLex - formely Phlexglobal
Year - 2011
Mastering the Trial File: Understanding Essential Documents from PharmaLex - formely Phlexglobal
Year - 2011
References
References available upon request.
Timeline
Program Manager
TATA Consultancy Service (TCS)
01.2023 - Current
Project Manager
TATA Consultancy Service (TCS)
07.2021 - 12.2022
Assistant Manager - ETMF Operations
TATA Consultancy Service (TCS)
04.2017 - 06.2021
Sr. Regulatory Records Specialist - eTMF
INC Research (Syneos Health)
05.2014 - 03.2017
Team Lead - eTMF (Records and Information Management)
Syntel Inc.
06.2013 - 04.2014
Clinical Trial Administrator (eTMF) - Resource Operations
Phlexglobal Ltd.
07.2011 - 01.2013
Hospital Pharmacist
Shashi Nursing Home
10.2007 - 11.2008
Sales Executive
Shreya Life Science Pvt. Ltd
12.2006 - 09.2007
Project Management for Managers from IIT Roorkee
Year - 2024
Generative AI Overview for Project Managers from Project Management Institute (PMI)
Year - 2023
The Basics of Scrum from Project Management Institute (PMI)
Year - 2023
Manage Project Effectively from Effective Project Management Academy
Year - 2021
Remote Work and Virtual Collaboration Professional Certificate from CertiProf International
Year - 2021
Advanced Certification In Clinical Research Methodology from Indian Institute Of Business Management And Studies
Year - 2020
Scrum Foundation Professional Certificate from CertiProf International
Year - 2020
Clinical - Professional Development Program (C-PDP) from PharmaLex - formely Phlexglobal
Year - 2013
Introduction to Clinical Research and GCP from PharmaLex - formely Phlexglobal
Year - 2011
Mastering the Trial File: Understanding Essential Documents from PharmaLex - formely Phlexglobal
Year - 2011
Doctorate in Management Studies -
Indian Institute of Business Management and Studies (IIBMS)
Master in Pharmacology -
University of Hertfordshire
Bachelor of Pharmacy (B.Pharm) -
Rajiv Gandhi University of Health Sciences
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