GOWSALYA SENTHIL
Hyderabad
Summary
Clinical Research Professional with expertise in TMF operations, regulatory compliance, and document management. Demonstrates a commitment to quality through effective eTMF management and proactive inspection readiness. Leverages strong collaboration skills to support diverse global clinical trials and drive operational excellence.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Global Study Supply Support (GSSS)
Capegemini
Hyderabad
02.2026 - Current
- Maintain and archive study documentation in the electronic Trial Master File (eTMF) ensuring inspection readiness.
- Provide operational support to Clinical Supply Chain Study Leaders across multiple global clinical trials from study start-up to close-out.
- Managed clinical supply chain activities, ensuring accurate transfer orders, stock reconciliation, and quality checks to maintain supply integrity.
- Supported Investigational Medicinal Product (IMP) management by overseeing kit types, tracking shelf-life, and coordinating production planning, depot management, distribution, reconciliation, and destruction processes.
- Coordinate Clinical Supply Packaging Orders (CSPO) and support labeling and shipment preparation activities.
- Prepare and maintain shipment documentation (customs value, country-specific regulatory documentation such as US/China requirements) ensuring compliance before shipment preparation.
- Ensure compliance with GxP, regulatory requirements, study protocols, and clinical trial design elements such as endpoints, randomization, dosing regimens, cohort management, and stratification factors.
- Collaborated with cross-functional teams and supply chain partners to enhance operational efficiency in global clinical study supply operations.
TMF Specialist
ICON Clinical Research Private Limited
Chennai
02.2023 - 02.2026
- Primary responsibility mainly involves performing IRR review, EDL Review and Reconciliation before Audit Inspection for Multiple studies and sponsor within the timeline.
- Indexed and performed quality control of documents across four sponsor projects, maintaining accuracy, consistency, and compliance with agreed timelines.
- Ensured eTMF Inspection Readiness, maintaining timely and accurate document uploads for multiple sponsors.
- Achieved 100% daily productivity and 99% quality, directly supporting team targets.
- Processed, reviewed, and indexed critical study documents (e.g., FDAs, SRPs, FCTs, EUCTR, and IIP) ensuring compliance with ICH-GCP and 21 CFR Part 11.
- Conducted quality control checks, minimizing errors and ensuring audit-ready documentation.
- Ensured proper document classification, indexing, and retrieval for regulatory compliance.
- Assisted in site closeout activities, document finalization, and sponsor audits.
- Guided eTMF management during investigator site closeouts and regulatory inspections.
- Assisted in study startup activities, including configuring eTMF systems and setting document templates.
- Supported system enhancements and process automation, contributing to increased efficiency in TMF management.
- Collaborated with CRAs, study teams, and clients to resolve document-related queries.
- Conducted internal and external audits, verifying eTMF compliance with sponsor and regulatory requirements to ensure audit readiness.
- Acted as a liaison between study teams and sponsors, facilitating smooth document flow and compliance.
Clinical Research Coordinator
Sri Venkateshwara Hospitals
Bangalore
09.2021 - 02.2023
- Conducted over 50 site selection visits, 20 site initiation visits, 10 site closure visits, 3 audits, and multiple monitoring visits to ensure compliance and data integrity.
- Coordinated effectively with sponsors, sites, investigators, patients, and CROs.
- Performed subject screening, randomization, and visits while resolving queries within timelines.
- Supported trial initiation and investigator meetings while executing study per protocol and budget to facilitate timely project delivery.
- Ensured accurate data entry in sponsor systems while maintaining audit-ready documentation to support regulatory compliance.
- Maintained research protocols and compliance records.
- Experienced in CTMS, Rave EDC, IWRS, CLIN phone, AMBRA, ERT, and SUGAM Portal.
Education
B.Tech - Biotechnology
Bharathidasan University
Tiruchirapalli, India05-2021
Skills
- Clinical trial design
- Regulatory compliance
- Veeva Vault eTMF
- GCP knowledge
- Data management
- Data interpretation
- Quality control measures
- Microsoft systems expertise
- Detail orientation
- Critical thinking
- Project coordination
- Interpersonal skills
- Active learning and perceptiveness
- Wingspan knowledge
Certification
- ICH GCP Certification
- Certified Clinical Research Professional (CCRP)
- Good Laboratory Practices
- Drug Safety and Pharmacovigilance
Languages
- English
- Telugu
- Kannada
- Tamil
Timeline
Global Study Supply Support (GSSS)
Capegemini
02.2026 - Current
TMF Specialist
ICON Clinical Research Private Limited
02.2023 - 02.2026
Clinical Research Coordinator
Sri Venkateshwara Hospitals
09.2021 - 02.2023
B.Tech - Biotechnology
Bharathidasan University