Nivedha Sakthitharan
Bengaluru
Summary
Dynamic eTMF Manager with proven expertise at Excelya in regulatory compliance and document management. Recognized for enhancing quality control processes and achieving timely project milestones. Skilled in stakeholder collaboration and performance monitoring, ensuring data integrity and compliance throughout the TMF lifecycle. Passionate about optimizing clinical documentation for successful study outcomes.
Overview
7
7
years of professional experience
Work History
eTMF CTA | TMF Manager
Excelya
11.2024 - Current
- ETMF Study Setup & Management – Create and configure studies in eTMF Vault Clinical, updating study status from 'created' to 'planned' upon sponsor request
- TMF Planning & Oversight – Conduct TMF Kick-Off Meetings (KOM) 3–5 months before First Subject First Visit (FSFV) and finalize the TMF Plan 5 weeks before FSFV to ensure compliance and readiness
- Regulatory Compliance & Document Security – Manage sensitive documents throughout the TMF lifecycle, performing quarterly access reviews to ensure proper authorization and data integrity
- TMF Quality Management – Monitor TMF status, implement corrective actions, and provide quarterly support to TMF contributors to maintain compliance and completeness
- Stakeholder Collaboration – Participate in extended Clinical Trial Team (CTT) meetings every 3 months, providing TMF status updates and ensuring alignment with study teams
- Internal Quality Control (IQC) Reviews – Evaluate IQC reports, identify quality issues, and provide actionable feedback to improve documentation accuracy
- TMF Archiving & Closure – Initiate pre-archiving requests, conduct TMF closure meetings within 10 working days post-Database Lock (DBL), and ensure timely transition to the archiving phase
- Final eTMF Lock & Compliance – Lead pre-lock meetings 1–2 months before the planned TMF lock and ensure eTMF lock is completed 3 months after the actual Clinical Study Report (CSR) approval date
eTMF CTA | TMF Specialist
Excelya
05.2023 - 10.2024
- Document Quality Review – Ensure timely and accurate quality checks for all eTMF uploads, maintaining compliance and inspection readiness
- Quality Issue Management – Identify, track, and resolve quality issues within established timelines
- Document Approval & Compliance – Approve documents that meet quality standards and escalate unresolved issues as needed
- Audit & Inspection Support – Assist project managers in audits and inspections, ensuring documentation meets regulatory requirements
- ETMF Management – Oversee eTMF setup, transformation (pTMF to eTMF), and transfers between Excelya and Sponsors
- Performance Monitoring – Track and ensure Key Performance Indicators (KPIs) are met for eTMF processes
- Process Optimization – Support root cause analysis and corrective action planning for recurring documentation issues
- Operational Support – Perform additional tasks as assigned to support Excelya’s clinical documentation processes
TMF Specialist II
ICON Clinical Research
08.2022 - 04.2023
- Document Management – Process study documents, including copying, filing, scanning, indexing, quality control, and archiving, ensuring compliance with ICON SOPs/WPs and regulations
- Quality Control & Reporting – Conduct internal QC checks and generate study-specific reports such as quality reports, internal timeliness, and trend-analysis reports
- Status Tracking & Metrics – Provide accurate and timely updates for Planview, Metrics, Master Study Tracker, and Initiative Tracker
- Stakeholder Coordination – Liaise with study teams, TMF staff, and clients to facilitate smooth document management processes
- Audit & Compliance Support – Assist in ICON/client audits and document archiving activities, ensuring regulatory adherence
- Training & Process Improvement – Participate in training programs and inform management of any training needs, quality issues, or project updates
- Special Projects & Client Requests – Manage client requests, special projects, and additional duties as assigned by the manager
Centralized Study Associate I
Covance Clinical Development Services
11.2019 - 08.2022
- TMF Management - Serve as the primary TMF classifier, ensuring accurate upload, review, and organization of study documents across multiple therapeutic areas.
- Regulatory Compliance - Oversee the end-to-end documentation process, ensuring adherence to sponsor requirements and regulatory standards.
- Clinical Systems Oversight- Manage clinical databases and systems, maintaining accurate and up-to-date study records.
- Quality Assurance- Conduct internal and external quality checks, including TMF reviews before key study milestones and audits.
- Stakeholder Communication- Lead study Kick-Off Meetings to align sponsors on eTMF requirements and provide biweekly updates on TMF status, proactively addressing potential issues.
- Issue Resolution - Collaborate with Clinical Research Associates (CRAs) to identify and resolve documentation discrepancies in a timely manner.
- Audit Preparation-Prepare audit checklists and support higher-level reviews to ensure TMF inspection readiness.
- Training & Mentorship- Train and mentor junior associates in eTMF processes, ensuring best practices in document management.
- Centralized Support- Act as the primary point of contact for study teams, addressing eTMF-related queries and ensuring compliance with study-specific requirements.
Clinical Research Co-Ordinator
M S Ramaiah Clinical Research Center
06.2018 - 05.2019
- Performing pre-trial works which includes CDA signatures, completing the feasibility questionnaires coordinating with PI
- Coordinate with CRA during Site Selection visit and provide required documents to CRA
- Coordinate with PI and Subjects during pre-screening activities, Consenting, study visits, laboratory assessments and writing source documentation
- Responding protocol related queries to Investigator, coordinating response to study related queries to data management and involves in data review and validation
- Perform timely data entry of the Case Report Form (CRF) and Electronic Case Report Forms (eCRF) in consultation with Principal Investigator and regulation of data queries
- Assist CTL an CRAs during Co-Monitoring visits thus the conduct of clinical trials, especially subject safety, quality, and site adherence to specific regulations and ICH GCP guidelines
- Reconciliation of SAE and ensure SAE and AE are reported accurately as per regulatory requirements in a timely manner and preparation of Clinical Study Report Appendices
- Support Clinical Trial team by updating and maintaining clinical systems that track site compliance and performance within project timelines
- Coordinating submissions to Ethics Committee for approvals and notifications of Fresh protocols, study Documents during Initial submissions, Amendments, Annual Reports, Periodic Safety Reports
Education
PG Diploma - Clinical Research and Pharmacovigilance
Institute of Clinical Research India (ICRI)
Bengaluru, Karnataka, India01.2018
MSc - Biotechnology
PSG College of Arts & Science
Coimbatore, Tamil Nadu, India01.2017
BSc. - Biotechnology
PSG College of Arts & Science
Coimbatore, Tamil Nadu, India01.2015
Advance Diploma - Bioinformatics
PSG College of Arts & Science
Coimbatore, Tamil Nadu, India01.2015
Skills
- Medidata
- eTMF management
- Regulatory compliance
- Document management
- Quality control
- Process optimization
- Stakeholder collaboration
- Audit support
- Performance monitoring
- Project management
- Data integrity
- Work Planning and Prioritization
- Scheduling and coordinating
- Trend analysis
- Veeva Vault
- MS Office
- OnCORE
Training
- GCP E6R2, MS Ramaiah Clinical Research Centre, 09/2018
- OnCore, Forte Research Centre, 06/2019
Personal Information
Title: eTMF Clinical Trial Assistant | TMF Manager
Date And Signature
Nivedha Sakthitharan, 04/29/24
Accomplishments
· Received ACE Award for Consistent Top Performer
· Received ACE Award for involving actively Engagement Activities
· Received ACE Award for Maintaining timelines in deliveries.
Languages
English
First Language
Malayalam
Advanced (C1)
C1
Tamil
Proficient (C2)
C2
Hindi
Upper Intermediate (B2)
B2
Telugu
Intermediate (B1)
B1
Kannada
Beginner (A1)
A1
Timeline
eTMF CTA | TMF Manager
Excelya
11.2024 - Current
eTMF CTA | TMF Specialist
Excelya
05.2023 - 10.2024
TMF Specialist II
ICON Clinical Research
08.2022 - 04.2023
Centralized Study Associate I
Covance Clinical Development Services
11.2019 - 08.2022
Clinical Research Co-Ordinator
M S Ramaiah Clinical Research Center
06.2018 - 05.2019
PG Diploma - Clinical Research and Pharmacovigilance
Institute of Clinical Research India (ICRI)
MSc - Biotechnology
PSG College of Arts & Science
BSc. - Biotechnology
PSG College of Arts & Science
Advance Diploma - Bioinformatics
PSG College of Arts & Science