Yash Chavan
Bengaluru
Summary
Results-driven Analyst with Eli Lilly, skilled in quality review of datasets and stakeholder coordination. Proven track record in enhancing data integrity through effective discrepancy management and communication. Adept at utilizing Rave and Veeva EDC, leading teams to achieve project goals while fostering collaboration and maintaining high standards of clinical data quality.
Overview
4
4
years of professional experience
Work History
Analyst
Eli Lilly
Bengaluru
07.2024 - Current
- Worked on COVID and oncology studies.
- Performed medical review of safety listings to ensure accuracy, completeness, and consistency of clinical data.
- Maintained regular communication with VP-level stakeholders regarding medical listing reviews and updates.
- Collaborated with programmers to develop and enhance listing programs tailored to study-specific needs.
- Conducted validation of programmed checks to ensure proper functionality and compliance with protocol requirements.
- Assumed responsibility for study oversight in the absence of the Study Lead, ensuring continuity of deliverables and team coordination.
- Executed Serious Adverse Event (SAE) reconciliation in alignment with company and regulatory standards.
- Managed and conducted manual reviews of clinical data to identify discrepancies and ensure data quality.
- Led and performed eCOA (electronic Clinical Outcome Assessment) reconciliation, addressing data issues and improving data integrity.
- Assigned tasks and managed workload distribution among Third-Party Operators (TPOs) to ensure timely delivery.
- Coordinated effectively with TPO representatives to align project goals, resolve queries, and track deliverables.
Clinical Data Coordinator I
Icon Plc
Bengaluru
02.2022 - 06.2024
- UAT
- Worked on COVID and oncology studies.
- Responsible for deliverables of multiple studies.
- Reporting of CRF and listing errors found during study conduct.
- Ensure adherence to study project plan and quality of work.
- Query management.
- Performed different data listing reviews like DM listing, Non ASCII Listing, Structural Listing, CDRP Listing, CSP Listing.
- External data reconciliation (SAE, IVRS, Central lab, PK etc.) and coordinated with External Data Vendors in respect to the reconciliation of Issues. Including updating the Non-CRF data reconciliation guideline as per study requirement.
- EDC Data Review - via Auto queries, manual review checks and query management.
- Performing SAE reconciliation.
- Reports generation (Ad hoc report, Screen failure tracker, Page status report, Metrix preparation, RPF report, NAR Analysis report, CPT etc.).
- Reports review.
- Identifying issues during study conduct and communicating findings to DMPM and CDL, also discussion of issues with team members.
- QC of the activities performed by the team.
- Managing activities of revision if occurred due to any discrepancy.
- Sending weekly or monthly metrics to the sponsor, CRA and DM team.
- Develop and maintain good communications and working relationships with the CDM team.
- Worked in one of the studies to validate the edit specification.
- Created customized reports in BO4 Module.
- Reviewed and followed project timelines.
- Understanding study lock timeline and updating the timeline as agreed by the team.
- Performing database lock and freezing.
- Reviewing SAS datasets.
Intern
AIT Global
Pune
03.2021 - 09.2021
- Project 1 - Development of Web Application on Company Dashboard.
- Engineered a dynamic dashboard utilizing AngularJS, HTML, CSS, JavaScript, and NodeJS to empower company employees with instant visibility into their daily schedules, profiles, and project-related information.
- Project 2 - Sales Prediction Model for Food staple Website Using Machine Learning.
- Created a monthly and yearly sales prediction model for the company's food staple website, enabling vendors to analyze sales trends and accurately predict future sales.
- Utilized AngularJS, HTML, CSS, JavaScript, Node JS, and Python to develop the sales prediction model.
- Implemented data visualization techniques to present the sales analysis in a clear and comprehensible manner.
Education
M.Sc. - Bioinformatics
Amrita School of Biotechnology
Amritapuri05.2022
B.Sc. - Bioinformatics
MGM's Institute of bioscience and technology
Aurangabad08.2020
Skills
- Quality review of datasets
- Discrepancy management
- Rave classic
- Rave X
- Veeva EDC
- Stakeholder coordination
- Query management
- Communication
- Technical skills
- Presentation skills
- Interpersonal skills
- Excel
- Computer skills
- Analytical skills
- MS Word
- MS Excel
- MS PowerPoint
- NGS
- HTML
- CSS
- JavaScript
- JAVA
- Python
- R
- Leadership skills
- Organizational skills
- Team player
Accomplishments
- Have been awarded for successfully completing the DBL of Covid study of an eminent sponsor and for completing all assigned activities in a given timeframe in strict timelines.
- Have been awarded for winning excel quiz conducted in all ICON India offices 4 times consecutively with first rank and been appointed as excel SME team member.
Languages
- English
- Hindi
- Marathi
Disclaimer
I do hereby declare that the above information regarding me is true & correct to the best of my knowledge., MM/DD/YY, Yash Chavan, Bangalore
Personal Information
- Date of Birth: 05/22/00
- Gender: Male
Activities
- Trained newly joined CDCs on study specific tasks.
- Trained CDCs on excel and study related problem solving using excel.
- Performed QR activities for different studies.
Timeline
Analyst
Eli Lilly
07.2024 - Current
Clinical Data Coordinator I
Icon Plc
02.2022 - 06.2024
Intern
AIT Global
03.2021 - 09.2021
M.Sc. - Bioinformatics
Amrita School of Biotechnology
B.Sc. - Bioinformatics
MGM's Institute of bioscience and technology
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