Judha Stanley T
Bengaluru
Summary
I have 8 years and 5 months of total professional experience, I have extensive experience as a TMF Manager, specializing in Veeva Vault and Wingspan systems, with a strong focus on quality review, access management, and maintaining inspection readiness. I am skilled in driving eTMF metrics, collaborating with functional managers for continuous process improvements, and ensuring compliance with regulatory standards. My background includes managing user access for eTMF and CTMS platforms, as well as project management and Clinical Trial Management (CTM) administration tasks. Currently, I serve as a Senior Document Management Associate (Acting TMF Lead), overseeing eTMF and performing periodic QC/quality reviews.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Document Management Associate
Novotech
12.2024 - Current
- Oversee eTMF operations as a Senior Document Management Associate ( Acting TMF Lead and TMF reviewer), ensuring inspection readiness and regulatory compliance.
- Conducted Kick-Off Meetings (KOM) for periodic quality reviews and reviewed Essential Document Lists (EDLs) for completeness.
- Performed risk-based sampling reviews, IR (Inspection Readiness) marking, and eTMF coherence/reconciliation to identify missing documents.
- Followed up with study teams to resolve Quality Issues (QIs) and placeholders, and conducted quality review closure meetings.
- Signed and filed quality review evidence in the eTMF.
- Drove eTMF completeness, timeliness, and quality by monitoring metrics and coordinating with study teams.
- Shared closeout and archival dashboard report to facilitate smooth eTMF archival and closure.
- Led efforts to ensure CTMS updates were completed to support periodic QC and eTMF reviews.
- Identified gaps in the Final Document List (FDL) and provided actionable feedback to FDL owners.
- Acted as a mentor to Document Management Associates (DMAs) by providing training and guidance.
- Identified study-level gaps and proactively communicated issues to Project Managers (PMs) for resolution.
- Supported audit preparation activities and provided assistance across multiple studies as needed.
Senior TMF Specialist
Icon Plc
04.2024 - 12.2024
- Performed file reviews and periodic quality reviews for PM, CTM, CRA, and SSU organizations in the Wingspan eTMF system.
- Trained team members and shared best practices for quality review processes across the team.
- Evaluated review team performance and addressed challenges faced during the review process.
- Served as Subject Matter Expert (SME) for the quality review team in TMF operations meetings.
- Acted as Point of Contact (POC) for multiple studies, leading file review tasks and coordinating quality review allocations.
- Identified gaps in eTMF filing patterns and collaborated with management by providing feedback and process improvement suggestions.
- Applied critical thinking to help resolve eTMF documentation gaps and improve filing accuracy.
- Developed logic frameworks to support the quality review team in conducting efficient eTMF quality reviews.
- Completed periodic file reviews and filed corresponding file review checklists in compliance with SOPs.
- Actively contributed as a member of a key committee within the eTMF department.
- Worked closely with Project Managers to identify and resolve eTMF gaps and ensure study document completeness.
- Led continuous process improvement initiatives in both quality review operations and eTMF management practices.
- Identified quality issues and missing documents in eTMF, assigned resolution tasks to study teams, and verified closure upon issue resolution.
- Reviewed study item lists to detect missing documents or placeholders and initiated corrective actions.
TMF Specialist-III
Icon Plc
07.2022 - 03.2024
- Performed file reviews and periodic quality reviews for PM, CTM, CRA, and SSU organizations in Wingspan eTMF.
- Acted as Point of Contact (POC) for multiple studies, leading file review tasks and coordinating review allocations with study teams and quality reviewers.
- Identified gaps in eTMF documentation and filing patterns, providing feedback and process improvement suggestions to management.
- Supported the quality review team by developing logical approaches to streamline eTMF quality review processes.
- Conducted periodic file reviews and completed corresponding file review checklists in compliance with SOPs.
- Served as a member of a key committee within the eTMF department, contributing to quality initiatives and process enhancements.
- Worked closely with Project Managers to identify and resolve eTMF gaps and ensure document completeness.
- Led continuous improvement initiatives focused on enhancing quality review practices and eTMF processes.
- Identified missing documents and quality issues within eTMF, coordinated with study teams for resolution, and finalized file reviews accordingly.
- Reviewed study item lists to detect missing documents or placeholders and initiated corrective actions.
Project Assistant-I / Clinical Trial Coordinator-Central
PPD, Part of Thermo Fisher Scientific
03.2020 - 06.2022
- Performed file reviews and periodic quality reviews for PM, CTM, CRA, and SSU organizations in Veeva Vault eTMF.
- Set up file review templates for upcoming reviews and maintained consistency in review processes.
- Generated reports for eTMF completeness, timeliness, and quality issues, and shared them with project and functional leads for action.
- Managed clinical project-specific training, ensuring eTAL (electronic Training Attendance Log) alignment with the study team list, requesting PPD Learns training codes, setting up eTAL wizard, and assisting in training compliance verification.
- Sent regular eTAL compliance updates to functional and project leads, escalating issues of non-compliance when necessary.
- Assisted study team members with study-specific trainings and guided them in recording completions in PPD Learns.
- Reviewed and updated study-specific information and training materials as needed.
- Performed study-level, country-level, and site-level file reviews within the eTMF.
- Managed mass communications to sites and coordinated messaging activities.
- Documented minutes for sponsor and internal project meetings.
- Oversaw study system access management, ensuring appropriate user permissions.
- Filed study-level and all-level documents into both PPD and sponsor eTMF systems in compliance with filing standards.
- Maintained and updated team lists by regularly coordinating with project and functional leads.
- Provided administrative support to project leads, assisting in study documentation and project coordination tasks.
Clinical Research Coordinator
Clinsolve Pvt Ltd
02.2019 - 03.2020
- Facilitated and coordinated daily clinical trial activities, playing a key role in the overall conduct and success of the study.
- Scheduled subject appointments and acted as the primary liaison between patients, Principal Investigators (PIs), and participating physicians.
- Supported the informed consent process by clearly communicating study details to subjects, demonstrating thorough knowledge of protocol and consent requirements.
- Coordinated approvals for new study agreements and contracts, ensuring compliance with institutional and regulatory standards.
- Organized and attended sponsor site selection visits, routine monitoring visits, and study close-out visits.
- Completed case report forms (CRFs) accurately and extracted data from source documents in a timely manner.
- Responded promptly to data clarification requests to ensure data integrity and study timelines.
- Worked closely with PIs and departments to maintain compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
- Maintained subject screening logs, protocol deviation logs, and coordinated monitoring activities.
- Ensured availability of all materials needed for subject enrollment and study conduct.
- Established and organized essential study files, including regulatory binders and source documentation.
- Assisted PIs in submitting accurate and timely close-out documents to IRB/IEC and other regulatory authorities.
- Arranged secure storage of study documents per institutional policies and contractual requirements.
Key Account Executive
GlaxoSmithKline Pharmaceuticals Pvt Ltd
10.2015 - 05.2018
- Oversee eTMF operations as a Senior Document Management Associate ( Acting TMF Lead and TMF reviewer), ensuring inspection readiness and regulatory compliance.
- Conducted Kick-Off Meetings (KOM) for periodic quality reviews and reviewed Essential Document Lists (EDLs) for completeness.
- Performed risk-based sampling reviews, IR (Inspection Readiness) marking, and eTMF coherence/reconciliation to identify missing documents.
- Followed up with study teams to resolve Quality Issues (QIs) and placeholders, and conducted quality review closure meetings.
- Signed and filed quality review evidence in the eTMF.
- Drove eTMF completeness, timeliness, and quality by monitoring metrics and coordinating with study teams.
- Shared closeout and archival dashboard report to facilitate smooth eTMF archival and closure.
- Led efforts to ensure CTMS updates were completed to support periodic QC and eTMF reviews.
- Identified gaps in the Final Document List (FDL) and provided actionable feedback to FDL owners.
- Acted as a mentor to Document Management Associates (DMAs) by providing training and guidance.
- Identified study-level gaps and proactively communicated issues to Project Managers (PMs) for resolution.
- Supported audit preparation activities and provided assistance across multiple studies as needed.
Education
B.Tech - Biotechnology
Kalasalingam University
Virudhunagar, Tamil Nadu07.2015
AISSCE - 12th
Kendriya Vidyalaya
Madurai, Tamil Nadu05.2011
AISSE - 10th
Kendriya Vidyalaya
Madurai, Tamil Nadu05.2009
Skills
- TMF Management (eTMF, Veeva Vault, Wingspan)
- TMF Inspection Readiness and Audit Support
- Periodic QC and Quality Review Processes
- ETMF Metrics Monitoring and Reporting
- Access Management (eTMF, CTMS, SailPoint)
- Clinical Trial Documentation Oversight
- CTMS Administration and Maintenance
- Project Management and Coordination (PM/CTM)
- Regulatory Compliance and GCP Knowledge
- Process Improvement
- Stakeholder Collaboration and Communication
- SOP Development and Adherence
- Study Start-Up, Maintenance, and Close-Out TMF Activities
- Training and Mentoring Study Teams on eTMF Best Practices
Certification
- Advance certification in clinical research, data management and phamacovigilance with medical coding.
- 2 day workshop on business intelligence using power BI
Timeline
Senior Document Management Associate
Novotech
12.2024 - Current
Senior TMF Specialist
Icon Plc
04.2024 - 12.2024
TMF Specialist-III
Icon Plc
07.2022 - 03.2024
Project Assistant-I / Clinical Trial Coordinator-Central
PPD, Part of Thermo Fisher Scientific
03.2020 - 06.2022
Clinical Research Coordinator
Clinsolve Pvt Ltd
02.2019 - 03.2020
Key Account Executive
GlaxoSmithKline Pharmaceuticals Pvt Ltd
10.2015 - 05.2018
B.Tech - Biotechnology
Kalasalingam University
AISSCE - 12th
Kendriya Vidyalaya
AISSE - 10th
Kendriya Vidyalaya
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