JYOTI SURYAVANSHI
Ambernath
Summary
Dynamic Clinical Data Reviewer with extensive experience at Omega Healthcare Pvt. Ltd., specializing in data reconciliation and regulatory submissions. Expert in managing discrepancies and ensuring strict compliance with ICH-GCP guidelines. Notable for training new staff and improving team performance, showcasing strong analytical abilities, and a dedication to quality in clinical research.
Overview
8
8
years of professional experience
Work History
Clinical Data Reviewer
Omega Healthcare Pvt Ltd.
Navi Mumbai
02.2022 - Current
- Patient Management: I efficiently handle patient scheduling, coordinate lab and radiology orders, and liaise with doctors and office coordinators to ensure seamless execution of visits. Post-visit, I meticulously review medical records to confirm completeness.
- Data Management: I am responsible for accurate and timely data entry into EDC and CTMS after visit completion. My work is consistently aligned with ICH-GCP guidelines, ensuring high-quality, compliant data handling.
- Query Management: I am responsible for closing out EDC open queries, along with data and SAE reconciliation when and where required.
- Regulatory Submissions: My experience includes preparing and submitting a range of regulatory documents to IRBs, such as retrospective deviations, administrative updates, progress and closure reports, amendments, and IB forms. I ensure that all submissions meet regulatory requirements and deadlines.
- Global Collaboration: I actively participate in biweekly global meetings to review the progress of ongoing clinical trials, contributing to the strategic oversight and continuous improvement of research activities.
- Protocol Transfers: I handle protocol transfer tasks efficiently, ensuring smooth transitions and continuity in the research process.
- Technical Proficiency: I possess practical experience with a range of EDC platforms, including RAVE, iMedidata, CTMS, PIMS, Tableau, Redcap, DF Explorer, CTSU, SEDES, and eRDS, demonstrating my versatility and technical acumen.
- Training and Support: I provide valuable support and training to new staff, facilitating their integration into projects, and ensuring they are equipped to contribute effectively.
- Team Handling: Managed escalations within the team, ensuring prompt resolution. Coordinate with internal team members to address queries, provide timely resolutions, and address quality challenges.
- CAPA: Applied RCA techniques for corrective and preventive measures.
- Documentation: Proficient in handling documentation for APQR (Annual Product Quality Report) and process verification.
Clinical Data Analyst
Inventurus Knowledge Solution Pvt Ltd
12.2018 - 02.2022
- Engaged in DMDA process and CDM projects involving Milford, PCPO, USMD, THC, and CMM CPR.
- Abstraction of data from legacy EHR to new EHR as per client requirements.
- Transferred family history and disease records from base EHR to updated EHR.
- Extracting data from medication records to the EHR software, and working on source data verification.
- Monitored and flagged discrepancies during EHR migration to ensure patient safety.
- Look for the labs done and labs value.
- Involved as a SME for team members, and conducted training for new joiners in the team.
- Assisted in ensuring that corporate and departmental quality and productivity targets are achieved.
- Conducted performance evaluations and guided professional development.
- Maintained and ensured that department metrics are collected, and expected targets are met.
- Monitored compliance with SLAs, SOPs, KPIs, and other agreed-upon benchmarks.
Management Trainee – R&D (API)
Asolution Pharma Pvt. Ltd
07.2017 - 03.2018
- Worked in the core research of active pharmaceutical ingredients.
- DMF filing for a new research drug, as per regulatory specifications.
Education
Clinical SAS Program -
EMRTI (Empower Research And Training Insttitute)
01.2024
Lean Six sigma green belt. -
Indian School of Professional Excellence
01.2022
Bachelor of Pharmacy (B.Pharm) -
Y.T.I.P Institute of Pharmacy, Mumbai University
Mumbai University01.2016
Skills
- Internal auditor
- Discrepancy/Query management
- Data entry
- EDC, Imedidata (Rave, Inform, Veeva Vault)
- EMR-EPIC, Nexgen
- EHR
- Protocols
- Data Reconciliation (SAEs, Labs)
- Corrective and Preventive Action (CAPA)
- Power BI
- eTMF
- Advanced Excel
- RCA analysis
Affiliations
- In Omega Healthcare, I was recognized three times, and received the Star Performer certificate
- Got an Opportunity in Implementing Lean Six sigma GB tools (VSM)
Timeline
Clinical Data Reviewer
Omega Healthcare Pvt Ltd.
02.2022 - Current
Clinical Data Analyst
Inventurus Knowledge Solution Pvt Ltd
12.2018 - 02.2022
Management Trainee – R&D (API)
Asolution Pharma Pvt. Ltd
07.2017 - 03.2018
Clinical SAS Program -
EMRTI (Empower Research And Training Insttitute)
Lean Six sigma green belt. -
Indian School of Professional Excellence
Bachelor of Pharmacy (B.Pharm) -
Y.T.I.P Institute of Pharmacy, Mumbai University
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