NEHA UTTAM SABLE
Thane
Summary
Experienced Clinical Study Associate and Clinical Trainer with over 6 years of experience in global clinical trials from start-up to close-out. Skilled in Veeva Vault, eTMF, CTMS, Medidata RAVE, and IxRS. Strong in clinical document management, site coordination, and regulatory compliance. Experience in training new team members, supporting study teams, and maintaining audit and inspection readiness. Good at working with vendors, CROs, and global teams to ensure smooth project delivery. Known for being detail-oriented, organized, and a strong team player. Awarded for high performance and mentoring skills.
Overview
6
6
years of professional experience
Work History
CLINICAL STUDY ASSOCIATE TRAINER
TATA CONSULTANCY SERVICES
05.2023 - Current
- Conducted onboarding and process training sessions for new associates.
- Followed structured training plans aligned with company standards.
- Provided continuous mentorship to ensure smooth role transition.
- Supported team members with real-time guidance and feedback.
- Maintained accurate training records and updated training materials.
- Created and revised SOPs, work instructions, and user manuals.
- Ensured all training activities followed ICH-GCP guidelines and SOPs.
- Promoted process compliance and quality standards.
- Evaluated new trainers, offered constructive feedback, and certified them for training delivery.
- Collaborated with leads and support teams to resolve associate queries.
- Reported training-related challenges to management for improvement.
CLINICAL STUDY ASSOCIATE
Tata Consultancy Services
09.2019 - Current
- Company Overview: Global Clinical Trial Execution & Oversight
- Provided end-to-end operational support across Phase I-IV global clinical trials, ensuring alignment with GCP, ICH, and SOPs.
- Collaborated with Study Management Teams (SMTs), Country Affiliates, CROs, and vendors to drive study milestones and resolve operational barriers.
- Supported clinical trial start-up, conduct, and close-out activities, maintaining compliance and high-quality delivery.
- Utilized platforms including Veeva Vault, eTMF, Medidata RAVE, CTMS, IxRS, and CLARA to track site progress, subject data, and document completeness.
- Ensured data accuracy and reconciliation across systems, supporting audit readiness and regulatory compliance.
- Provided technical guidance on CTMS workflows, interface issues, and real-time data updates.
- Managed vendor platforms (IxRS, QNET, Central Labs), proactively resolving technical issues and ensuring continuous trial conduct.
- Processed and tracked user access management for sponsor and third-party systems, ensuring site readiness and regulatory training compliance.
- Uploaded, classified, and QC'ed essential trial documents in Veeva Vault/eTMF to meet inspection readiness and document lifecycle requirements.
- Supported Regulatory Document Package compilation: tracked and managed FDA Form 1572, Financial Disclosure Forms (FDFs), and investigator CVs.
- Global Clinical Trial Execution & Oversight
eTMF DOCUMENT SPECIALIST
Tata Consultancy Services
05.2019 - 09.2019
- Managed essential clinical trial documents within the electronic Trial Master File (eTMF) system across all study phases.
- Ensured document accuracy, completeness, and timely uploads in accordance with ICH-GCP, FDA, and other regulatory requirements.
- Collaborated with study teams to streamline document handling processes and improve communication efficiency.
- Prepared the eTMF for audits and inspections by identifying and resolving discrepancies, ensuring document quality and compliance.
- Acquired hands-on experience with clinical trial documentation and lifecycle management across Phases I-IV.
Education
M.Sc(Science) - Biotechnology
Pune University
01.2018
Biotechnology - undefined
Pune University
01.2016
Skills
- Communication Skills
- Presentation Skills
- Team Leading
- Hard Working
- Quick Learner
- Etmf
- ICH-GCP
- Shared Investigators platform
- Rave
- EDC
- IXRS
- Training
- Training management
- Team Coordination
- Query Management
- Creative Thinking
- Honesty
Languages
English
Hindi
Marathi
Recognition
- Commended by college faculty and peers for exceptional leadership, academic excellence, and impactful presentations.
- Appreciated by global clients for timely, accurate clinical documentation and proactive follow-ups during trial phases.
- Recognized by team leads and colleagues for a strong work ethic, reliability, and effective problem resolution in high-pressure environments.
<Enter your own>
- Title: CLINICAL STUDY ASSOCIATE
- Nationality: INDIA
Achievements And Awards
- TCS Star Performer Award (2020, 2022)
- Recognized CSA Front Runner - Mentorship & Process Improvement
- Adarsh Vidyarthini Award - Academic Excellence
- Winner - Elocution, Drawing, and Sanskrit Kavyavachan Competitions
- Ranked 1st in B.Sc. Biotechnology
Timeline
CLINICAL STUDY ASSOCIATE TRAINER
TATA CONSULTANCY SERVICES
05.2023 - Current
CLINICAL STUDY ASSOCIATE
Tata Consultancy Services
09.2019 - Current
eTMF DOCUMENT SPECIALIST
Tata Consultancy Services
05.2019 - 09.2019
M.Sc(Science) - Biotechnology
Pune University
Biotechnology - undefined
Pune University
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