Vibhusha Dangore
Clinical Trial Specialist
Pune
Summary
Detail-oriented Clinical Trial Professional and eTMF Specialist with over 8 years of experience in clinical research and trial documentation. Expertise in managing global clinical studies, ensuring regulatory compliance, and overseeing eTMF systems, including Veeva Vault. Proficient in cross-functional coordination and effective sponsor communication, with a proven track record of driving inspection readiness throughout all phases of clinical trials. Committed to delivering high-quality results that support the advancement of clinical research initiatives.
Overview
9
9
years of professional experience
1
1
Language
Work History
Senior Process Associate- eTMF Management
Tata Consultancy Services
02.2022 - Current
- Oversee planning, structuring, filing, indexing, and archiving of eTMF documentation throughout study start-up, conduct, close-out, and archival phases.
- Oversee eTMF activities for multiple global trials across Phases I–III, ensuring 100% compliance with SOPs and GCP.
- Manage Essential Document Lists (EDLs) and monitor TMF health metrics: completeness, timeliness, and quality; produce status reports, and dashboards for stakeholders.
- Perform QC reviews and resolve Quality Issues (QIs), escalations, and discrepancies to ensure inspection readiness and compliance with client SOPs, the TMF Reference Model, and ICH-GCP guidelines.
- Conduct defect management, including logging, tracking, and verifying fixes.
- Identify and resolve data quality issues at the business level, ensuring compliance with regulatory standards.
- Work closely with stakeholders to validate requirements, and deliver high-quality solutions.
- Serve as a single point of contact for eTMF-related queries, coordinate with clinical teams, CROs, QA, and other stakeholders to address filing practices and documentation needs.
- Manage TMF completeness and quality through regular QC checks, TMF health checks, and audits.
- Met month-end reporting objectives and deadlines.
- Identified modifications to processes and procedures that would promote better efficiency.
- Supervised team of process associates to enhance accountability, develop professional skills and improve efficiency.
- Increased customer satisfaction by promptly addressing concerns and providing effective solutions tailored to their needs.
- Trained junior associates in various process-related tasks, ensuring consistent quality across the team.
- Managed critical projects, successfully meeting deadlines while maintaining high-quality outputs.
- Maintained accurate documentation of processes, facilitating easy reference for internal audits and knowledge transfer.
- Assessed risk factors in business processes, proposing mitigation strategies to minimize potential issues.
- Collaborated with cross-functional teams to improve overall process performance and client satisfaction.
Associate- Clinical Operations
Excel Life Sciences Private Limited (An IQVIA group of company)
04.2018 - 02.2022
- Coordinate the preparation and submission of regulatory documents (e.g., IRB/IEC submissions).
- Help recruit and screen study participants based on inclusion/exclusion criteria.
- Obtain and document informed consent from participants. Schedule and conduct participant visits.
- Collect, record, and manage clinical data (e.g., vital signs, lab results).
- Monitor participants for adverse events, and report them promptly.
- Ensure accurate and timely data entry in case report forms (CRFs) or electronic data capture (EDC) systems.
- Maintain essential study documents (source documents, consent forms, protocol amendments, etc.).
- Perform quality checks on collected data.
- Adhere to Good Clinical Practice (GCP) guidelines and local regulatory requirements.
- Assist in audits and inspections by sponsors, or regulatory authorities.
- Serve as the liaison between the sponsor, CRO, PI, and other stakeholders.
- Attend investigator meetings and training sessions.
- Manage study supplies (e.g., investigational products, lab kits).
- Track study progress and timelines, and maintain a financial log or budget-related documents when necessary.
- Supported trial site start-up, maintenance, and closeout activities.
- Assist in TMF document collection, filing, and review during each trial phase.
- Generated and tracked essential documents per ICH-GCP and study-specific requirements.
- Liaised between sponsors, investigators, and CROs to resolve TMF discrepancies.
Clinical Research Coordinator
Amclin Life Sciences Private Limited
Pune
03.2017 - 04.2018
- Study Preparation and Site Initiation.
- Participant recruitment and consent.
- Study Conduct and Data Collection.
- Regulatory and Compliance
- Safety and Adverse Event Reporting.
- Communication and coordination.
- Documentation and Records Management.
- Close-Out Activities.
Education
Post-Graduation Diploma - Clinical Research, Clinical Data Management and Pharmacovigilance
Mitcon Biopharma Centre, Department of Science & Technology, Gov. of India
Pune01.2017
B. Tech - Biotechnology
Rashtrasant Tukadoji Maharaj University
Nagpur01.2016
Skills
Veeva Vault expertise
eTMF System Management
Expertise in clinical systems including CTMS and EDC
Expertise in clinical trial regulations
Expertise in Clinical trial documentation
Expertise in ICH GCP E6 R3
Timeline
Senior Process Associate- eTMF Management
Tata Consultancy Services
02.2022 - Current
Associate- Clinical Operations
Excel Life Sciences Private Limited (An IQVIA group of company)
04.2018 - 02.2022
Clinical Research Coordinator
Amclin Life Sciences Private Limited
03.2017 - 04.2018
Post-Graduation Diploma - Clinical Research, Clinical Data Management and Pharmacovigilance
Mitcon Biopharma Centre, Department of Science & Technology, Gov. of India
B. Tech - Biotechnology
Rashtrasant Tukadoji Maharaj University
CORE COMPETENCIES
- ETMF Management (Veeva Vault)
- Clinical Trial Operations (Phase I-IV)
- Regulatory Compliance (ICH-GCP, FDA, EMA)
- TMF QC/QA and Inspection Readiness
- CRO/Vendor Oversight
- Clinical Study Documentation Lifecycle
- TMF Process Training
- Audit Support (Internal & External)
EMPLOYMENT ACCOMPLISHMENT
- Awarded by Client for excellence in Accuracy and Quality in eTMF management, effective communication and proactive issue resolution.
- Awarded as “Star of the Month” by Tata Consultancy Services total 5 times in the Year 2022, 2023 and 2024 respectively.
- Awarded as “Star of the Quarter” two times in the year 2018 and one time in the year 2019 respectively by Excel Life Sciences.
- Awarded as “Star Performer of the Year” in the financial year 2018-2029 by Excel Life Sciences.
- Successfully managed total 10 global clinical trial sites across multiple therapeutic areas, ensuring 100% compliance with ICH-GCP and sponsor protocols.
- Contributed to the successful completion of a global Phase III trial with highest patient recruitment and best quality. Led the 3 high researching sites in Pune.
- Recognized by Excel Life Sciences/ IQVIA and sponsors for excellence in site relationship management and proactive issue resolution.
- Successfully cleared 6 sponsor audits and 2 regulatory inspection with zero critical findings.
THERAPEUTIC EXPOSURE
- Ophthalmology: 1. Retinal Vein Occlusion (Phase III Study) 2. Non-Infectious Uveitis (Phase III Study) 3. Adenoviral Conjunctivitis (Phase II Study) 4. Persistent Epithelial Defect (Phase-II study) 5. Diabetic Retinopathy (Phase III study)
- Cardiology: 1. Cardiovascular Diseases (Phase III Study) 2. Type-II Diabetes with Acute Coronary Syndrome (Phase III Study)
- Orthopedic: 1. Rheumatoid Arthritis (Phase III Study) 2. Osteoarthritis (BA/BE Study)
- Dermatology: 1. Atopic Dermatitis (Phase IV Study)