Summary
Overview
Work History
Education
Skills
DEPARTMENT SPECIFIC EXPERIENCE
Certification
Software
Timeline
Generic

Malarvizhi Dhanapal

TMF Lead
Chennai

Summary

Accomplished Trial Master File Specialist with 8+ years of comprehensive experience in clinical documentation management. Demonstrates exceptional problem-solving capabilities and consistently takes a proactive approach to new challenges. Distinguished by remarkable adaptability, creative solutions, and an unwavering results-oriented mindset. Committed to delivering meaningful contributions that drive organizational success and regulatory compliance. Possesses deep expertise in TMF processes, quality control, and regulatory standards across multiple therapeutic areas.

Overview

9
9
years of professional experience
1
1
Certification
3
3
Languages

Work History

TMF Lead

Parexel
11.2022 - Current
  • Participates in the study kick-off meeting and drives discussions regarding the design of the TMF plan.
  • Provides recommendations in terms of client expectations for TMF, including budget and resource implications.
  • Works with the PL to set realistic client expectations and enable client TMF oversight.
  • Coordinates TMF milestones in collaboration with the TMF reviewer and/or other TMF contracted tasks, according to the established timelines and quality criteria.
  • Provides input to relevant project guidelines, as required.
  • Proactively flags potential project risks in terms of TMF deliverables, and provides feedback to the project team and client to design solutions.
  • Leads or participates in internal monthly TMF review meetings, regularly providing TMF status updates.
  • Provides TMF expertise to manage client concerns in terms of TMF.
  • Identifies inconsistencies and inefficiencies in processes, and recommends solutions.


TMF Specialist (File Reviewer)

IQVIA
11.2021 - 11.2022
  • Conduct the Comprehensive Quality Trial Master File Review in accordance with eSOPs, Guidance Documents, File Review Overview Form, and Project Instruction, when applicable.
  • Review documents in line with ALCOA principles.
  • Focus on cross-checks, co-dependency checks, and identification of missing documents.
  • Identify metadata, and document inaccuracies as action items.
  • Create action items and assign them to users (document owners or self).
  • Raise valid and clear action items, as per the Action Item Response Table, or another applicable document.
  • Address action items assigned to yourself, and close them in accordance with review timelines.


TMF Specialist

ICON Clinical Research India Pvt. Ltd
10.2016 - 11.2021
  • Recognize, exemplify, and adhere to ICON’s values, which center around our commitment to People, Clients, and Performance.
  • Acquired knowledge and skills to process study documents in accordance with client and study requirements, as per study-specific processes, ICON SOPs/WPs, and regulations, where applicable.
  • Acquired knowledge and skills to complete activities related to document receipt and processing which may include but is not limited to document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
  • Responsible to liaise with study teams and other TMF Operations staff to fulfill job responsibilities and activities with supervision.
  • Liaise with study teams and other TMF staff to fulfill job responsibilities and activities.
  • Maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.


Education

B.E - Biomedical Engineering

Jerusalem College of Engineering
05-2016

Skills

  • Assertive and goal-oriented
  • Self-confidence
  • Cross-functional teamwork
  • Highly Ambitious
  • Customer service
  • Positive attitude

DEPARTMENT SPECIFIC EXPERIENCE

  • Extensive expertise in Veeva Vault eTMF (7 years)
  • Proficient in IQVIA Wingspan eTMF platform (2 years)
  • Experience with traditional paper TMF management (1 year)
  • Advanced skills in document indexing, quality control, and comprehensive file review

Certification

ICH-GCP guidelines by NIDA

Software

Veeva Vault

Wingspan

Timeline

TMF Lead

Parexel
11.2022 - Current

TMF Specialist (File Reviewer)

IQVIA
11.2021 - 11.2022

TMF Specialist

ICON Clinical Research India Pvt. Ltd
10.2016 - 11.2021

B.E - Biomedical Engineering

Jerusalem College of Engineering

Similar Profiles

CREATE PROFILE
Malarvizhi DhanapalTMF Lead