Onkar Pawar
Clinical Research Coordinator
Pune,MH
Summary
Results-driven professional with extensive experience in clinical research. Skilled in process improvement, documentation management, and cross-functional collaboration to enhance data integrity and compliance. Committed to driving efficiency and supporting successful clinical outcomes.
Overview
3
3
Languages
4
4
years of professional experience
6
6
years of post-secondary education
Work History
Clinical Research Coordinator
Lupin Digital Health
01.2024 - Current
- Clinical Data Abstraction and Verification: Conducted rigorous medical chart reviews and source data verification (SDV) across complex patient electronic medical records (EMRs) to extract, summarize, and interpret nuanced clinical data.
- Database Management & Entry: Entered patient medical histories, clinical endpoints, and adverse events into Veeva EDC and iMedidata platforms, achieving a near-zero error rate.
- Regulatory Compliance: Ensured absolute audit readiness and data integrity across electronic Trial Master Files (eTMF) and Case Report Forms (CRFs) in strict compliance with FDA, ICH-GCP, and HIPAA privacy mandates.
- Database Management & Entry: Utilized Veeva EDC and iMedidata platforms for high-accuracy entry of patient medical histories, clinical endpoints, and adverse events, while maintaining a near-zero error rate.
- Process Improvement & Guidelines: Developed internal Standard Operating Procedures (SOPs) and data quality assurance workflows, enhancing site-level data entry efficiency.
- Safety Tracking: Documented and tracked Adverse Events (AEs) and Serious Adverse Events (SAEs), ensuring immediate escalation and compliance with protocols.
- Stakeholder Communication: Acted as the primary data and regulatory liaison during sponsor monitoring visits and external audits, resolving findings promptly and effectively.
Program Coordinator & Counselor
Jehangir Clinical Developement Center
11.2022 - 12.2023
- Administered academic and career counseling to students leveraging performance data to develop tailored support plans that increased retention and engagement.
- Nurtured effective collaborations with faculty staff and external stakeholders to refine program delivery and enrich student experiences.
- Facilitated rollout of various new courses in partnership with academic teams, directing logistics and assuring timely execution.
- Coordinated event planning documentation and achieved 99% fee collection rate through prompt follow-ups.
- Cultivated strategic alliances through MOU agreements with educational and industry partners, enhancing institutional reach.
- Nurtured collaborations with faculty and external stakeholders to refine program delivery and enrich student experiences.
Education
MBA -
Pune University
Pune 06.2020 - 11.2022
Bachelor of Pharmacy -
Pune University
Pune 06.2016 - 05.2020
Skills
Clinical trial management
Good clinical practices
Adverse event reporting
Clinical Data Abstraction
Regulatory compliance
Regulatory Tracking Systems (eTMF, eCRF)
EMR management
Data Privacy (HIPAA compliance)
Document control
Process optimization
Cross-Functional Collaboration
Cardiology Specialization
Timeline
Clinical Research Coordinator
Lupin Digital Health
01.2024 - Current
Program Coordinator & Counselor
Jehangir Clinical Developement Center
11.2022 - 12.2023
MBA -
Pune University
06.2020 - 11.2022
Bachelor of Pharmacy -
Pune University
06.2016 - 05.2020