Piyali Roy
Bengaluru
Summary
Clinical Research professional with three years of experience in managing clinical trials, data review, and regulatory compliance. Known for strong analytical skills, attention to detail, and effective communication. Experienced in collaborating with global teams and committed to high ethical standards in clinical research.
Overview
3
3
years of professional experience
Work History
Clinical Data Analyst
Fortrea (Formerly Labcorp)
Bengaluru (Remote)
08.2023 - Current
- Perform all data management tasks, reviewed and managed queries, maintaining adherence to internal and client quality standards and meeting prescribed timelines as outlined in Data Management Plans.
- Develop Edit Check Specifications and/or Data Review Guidelines, and raise queries to resolve erroneous, missing, or incomplete data.
- Generate, resolve, and track queries to address problematic data identified during aggregate data review activities
- Executed various programs and listings such as special listings or reconciliation discrepancy listings to aid in the analysis of clinical trial data
- Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required
- Assist with review of data listings for internal data review
- Assisted in creating and testing dummy data to evaluate edit checks and validate database screen design
- Assist or create dummy data to test SAS reports and data listing
- Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
- Assist with the completion of Database Lock activities
- Support the training of new staff on project specific Data Management processes.
- Assist with Quality review of External data
- Coordinated and scheduled meetings with vendors to effectively resolve vendor issues and maintain data accuracy.
Assistant External Data Reviewer II
Fortrea (Formerly Labcorp)
Bengaluru, India
09.2022 - 07.2023
- Achieved efficient execution of departmental Standard Operating Procedures and Work Instructions
- Met quality expectations by promptly reviewing and addressing assigned queries, updating database as required
- Reviewed reports and executed actions according to DMP or eCRF review manual/ other relevant documents
- Executed ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) to aid in the review process of clinical trial data.
- Assisted with UAT tasks.
- Involved in performing data management system edits and data validation checks as part of special listings/procedures utilized for data review, vendor data reconciliation, and discrepancy management activities.
- Reviewed and assisted with External Data edit checks, status reports, and listings
- Entered local laboratory normal ranges in accordance with established protocols.
Assistant External Data Reviewer I
Fortrea (Formely Labcorp)
Bengaluru
05.2021 - 08.2022
- Follow departmental Standard Operating Procedures (SOPs) and Work Instructions.
- Review and action queries within specified timelines, ensuring quality expectations are met and updating the database accordingly.
- Review reports and take actions as defined in the Data Management Plan (DMP) or Electronic Case Report Form (eCRF) review manual and other relevant documents.
- Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) to support the review of clinical trial data.
- Support User Acceptance Testing (UAT) activities.
- Assist in reviewing External Data edit checks, status reports, and listings.
- Enter local laboratory normal ranges.
Education
M.Sc. microbiology -
The Oxford College of Science
Bangalore, KarnatakaB.Sc. microbiology -
Acharya Bangalore B School
Bangalore, KarnatakaSkills
- Performed all data management tasks, reviewed and managed queries, maintaining adherence to internal and client quality standards and meeting prescribed timelines as outlined in Data Management Plans
- Develop Edit Check Specifications and/or Data Review Guidelines, and raise queries to resolve erroneous, missing, or incomplete data
- Generate, resolve, and track queries to address problematic data identified during aggregate data review activities
- Executed various programs and listings such as special listings or reconciliation discrepancy listings to aid in the analysis of clinical trial data
- Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required
- Assist with review of data listings for internal data review
- Assisted in creating and testing dummy data to evaluate edit checks and validate database screen design
- Assist or create dummy data to test SAS reports and data listing
- Modified standard templates to develop study-specific Data Management Plans and eCRF completion guidelines
- Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
- Assist in the creation of slides for Investigator Meeting and Site Initiation Visit or similar meetings
- Assist with the completion of Database Lock activities
- Support the training of new staff on project specific Data Management processes
- Assist with Quality review of External data listing
- Coordinated and scheduled meetings with vendors to effectively resolve vendor issues and maintain data accuracy
- Continuous learning mindset
Therapeutic Experience
- Oncology: Lung Metastatic
- Brain Metastatic
- Breast Metastatic
Language Capabilities
- English
- Hindi
- Bengali
Languages
English
Upper intermediate (B2)
Hindi
Upper intermediate (B2)
Bengali
Intermediate (B1)
Timeline
Clinical Data Analyst
Fortrea (Formerly Labcorp)
08.2023 - Current
Assistant External Data Reviewer II
Fortrea (Formerly Labcorp)
09.2022 - 07.2023
Assistant External Data Reviewer I
Fortrea (Formely Labcorp)
05.2021 - 08.2022
M.Sc. microbiology -
The Oxford College of Science
B.Sc. microbiology -
Acharya Bangalore B School