Summary
Overview
Work History
Education
Skills
Core Competencies
Accomplishments
Disclaimer
Timeline
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Nimish Pawar

Pune

Summary

Seasoned Specialist with a proven track record in Clinical Record Management, adept in eTMF - Veeva Vault and mentoring new team members. Skilled in leveraging CTMS, Excel, and PowerPoint for comprehensive study management and reporting. Seeking a strategic role. Aiming to leverage my proven expertise in eTMF processes and guiding teams towards heightened efficiency and regulatory compliance.

Overview

9
9
years of professional experience

Work History

Centalized Study Specialist

Fortrea
Bengaluru (Remote)
08.2023 - Current
  • Process, coordination, and approval of clinical trial documents.
  • Managing eTMF for clinical studies in accordance with TMF processes, working with key study personnel such as the Clinical Lead and Project Managers.
  • Perform TMF Review, document classification. Also, perform ARC Review when required.
  • Maintain the TMF in a state of audit readiness for quality and compliance.
  • Responsible for gathering data requested by the study team and submitting status reports on a regular basis.
  • Process and track final essential artifacts required throughout all phases of study in accordance with SOPs and ICH GCP guidelines.
  • Attend internal and external study team meetings as required.
  • Review and respond to TMF content quality issues, and identify trends as per study. Alert line managers of trends.
  • Mentor new team members and conduct QC feedback and knowledge management session to improve TMF quality.
  • Perform QC of the TMF documents for multiple customers. Maintain tracker for the project-specific and customer-specific updates.

Document QC Specialist

IQVIA
Pune
10.2022 - 08.2023
  • Participate in filing, initial QC, and Classification of documents in TMF.
  • Perform detailed quality checks of documents uploaded into TMF.
  • Perform TMF checks and monitor TMFs for trends, quality, and completeness.
  • Communicate internal quality findings regarding TMF contents to stakeholders, TMF leads, and Managers.
  • Ensure that TMF filing is consistent with established processes and TMF specifications.
  • Provide support and feedback to study teams and eTMF functional leads on the resolution of quality issues.
  • Coordinate internal QC reviews of TMFs to ensure compliance and inspection readiness.
  • Verify essential documents are included in TMF and are in the correct official repository at closeout verification.
  • Statistics given to the line managers in Excel Spreadsheets weekly.
  • This assures statistics on all studies are up-to-date daily.
  • Mentoring and training of the new joiners in the team.

TMF Operations Associate

Tata Consultancy Services
Pune
03.2018 - 09.2022
  • Perform approvals, approvals with corrections, and rejections of Electronic Submission Workflows via TMF document management system according to SOPs and RIM approval workflow.
  • Maintain full understanding of study documentation properties in order to perform execution of clinical documentation activities.
  • Track and follow up on document discrepancies.
  • Communicate document/s, system, and hardware issues to support team/s.
  • Escalate unresolved issues appropriately to TCS team leads and Client support Team.
  • Provide support during internal and external inspections, including FDA audits.
  • Ensure that quality and TAT targets are always met.
  • Support business functions as directed by TMF operations leadership.
  • Provide process quality analysis reports to team leads and managers, as required.
  • Support internal process development initiatives.
  • Provide support to new employees.
  • Management of queries and discrepancies generated by team members.

Associate

Atos Syntel
Pune
12.2015 - 03.2018
  • Identification, Naming, and categorization of clinical documents as per Client's SOPs and eTMF guidance.
  • Importing documents to client repository in accordance with the Trial Master File.
  • Conducting 100% quality checks of all the documents, rectifying errors before final submission.
  • Updating MIS on a daily basis for possible query resolution.
  • Management of queries and discrepancies generated by team members
  • Adherence to regulations governing the process with ICH-GCP guidelines.
  • Provide floor support to the new employees in identification, naming, and categorization of clinical documents as per clients' SOPs and guidelines.
  • Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
  • Used Microsoft tools to create correspondence, edit spreadsheets, and develop presentations.
  • Team handling and training.

Education

Master of Pharmacy - Quality Assurance

Modern College of Pharmacy
Pune
06.2017

Bachelor of Pharmacy - Pharmaceutical Sciences

Siddhant College of Pharmacy
Pune
06.2014

Skills

  • eTMF - Veeva Vault
  • EPIC
  • CTMS
  • Subway
  • MS Word, Excel, and PowerPoint
  • SharePoint
  • TMF Reference Model
  • ICH GCP
  • 21 CFR Part 11
  • ALCOA Review

Core Competencies

  • Leadership
  • Problem Solving
  • Team Work and Collaboration
  • Multi Tasking abilities
  • Team Player

Accomplishments

  • Fortrea ACE Award- Process Excellence- February 2024
  • Fortrea ACE Award- Process Excellence- January 2024
  • TCS Service & Commitment Award- March 2021
  • SYNTEL Agile Value Award- Adaptive- Dec, 2017

Disclaimer

I hereby declare that the above mentioned particulars are true to best of my knowledge and belief.

Timeline

Centalized Study Specialist

Fortrea
08.2023 - Current

Document QC Specialist

IQVIA
10.2022 - 08.2023

TMF Operations Associate

Tata Consultancy Services
03.2018 - 09.2022

Associate

Atos Syntel
12.2015 - 03.2018

Master of Pharmacy - Quality Assurance

Modern College of Pharmacy

Bachelor of Pharmacy - Pharmaceutical Sciences

Siddhant College of Pharmacy

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Nimish Pawar