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
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)