Summary
Overview
Work History
Education
Skills
Certification
Industrial Exposure
Extracurricular Activities
Projects
Training
Accomplishments
Timeline
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MEGHANA EG

TMF Specialist
Bengaluru

Summary

Specialist TMF Management with over 3.10 years of experience in TMF expertise and project management, and a post-graduation diploma in clinical research, clinical data management, and pharmacovigilance. Expert in GCP, standard operating procedures, and with proficiency in document management. Key achievements include serving as a TMF subject matter expert and supporting ongoing TMF projects. Seeking a Document Specialist position at a company where I can utilize my TMF management skills to support the mission of successful clinical trial execution and global document management.

Overview

4
4
years of professional experience
1
1
Certification
3
3
Languages

Work History

Specialist TMF Management

Eli Lilly services India private limited
08.2022 - Current
  • Serve as TMF subject matter expert
  • Partner with internal colleagues to create metrics dashboard and reporting capabilities to demonstrate control of the TMF process
  • Support internal audits and external inspections, as appropriate (e.g
  • A table of contents based on the trial-specific TMF Expected Document Lists (EDLs)
  • Assists TMF Project Managers by supporting study teams with TMF related remediation and process execution inquiries
  • Assists TMF Project Managers in eTMF process related questions and answers
  • Provide support to ongoing and ad-hoc TMF projects and initiatives
  • Project Management Support execution of TMF Functional Checks for the trial throughout the life of the trial

ETMF Quality Reviewer

Accenture Solutions Private
05.2020 - Current
  • Quality reviews of electronic documents residing in the electronic trial Master file system
  • Uploaded documents to eTMF
  • Ability to make decisions based on evidence manual of operations and experience regarding outcome of the quality review of critical documents
  • Ensured quality reviews follow client standard operating procedures and directives, and that assigned quality reviews are appropriately documented
  • Check documents for Mandatory metadata based on document classification
  • Assist in training, mentoring of new hires and process changes
  • Support eTMF team for audit or inspection
  • Maintain eTMF database
  • Perform self evidence correction for issues specified by client
  • Proficiency in document management

Education

M.Sc. in Biotechnology -

Maharani Lakshmi Ammanni College (MLAC)

B.Sc. - Chemistry Botany & Zoology

M.E.S. College

PUC (State Board) -

K.L.E. College
Haveri, Karnataka

SSLC (State Board) - undefined

Haveri
Haveri, Karnataka

Skills

Have good hands on in SharePoint, Power BI

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Certification

Post-graduation diploma in clinical research, clinical data management and pharmacovigilance.

Industrial Exposure

  • Ramangara Silk Cocoon Market, Karnataka
  • Zumator Biologics, Bengaluru
  • BWSSB Sewage Water Treatment, Nayandahalli, Bengaluru

Extracurricular Activities

Commissioned in Inter-college Fest “Lakshaya” in 2015 Part of the NSS group at MES College in 2014-15 Volunteered in Bioengima at MLACW Active basketball player (Division level) Partook in various cultural and sports activities

Projects

Immobilized Lipase Producing Bacteria for Waste Water Treatment, 6 months (Dec’18 – May’19), This deals with Immobilized Lipase Producing Bacteria when isolated from Bacillus species and treatment was tested for the Ice Cream Factory Waste Water and STP Waste Water. This test exhibited significant reduction in the COD and BOD levels and reduction lipid content in the waste water. The viability of the immobilized bacteria indicated reusability of immobilized beads for many cycles for the treatment of waste water.

Training

  • Attended a workshop on Artificial Intelligence in Healthcare held at MLACW on September 7, 2018
  • Interacted at National symposium on Smart Synergy, emerging Trends in Application of Smart Materials on February 14, 2019
  • Participated in Wine Processing and Wine Tasting at Heritage Grape Winery Pvt. Ltd. on March 18, 2017
  • Engaged with Centre for Innovation and Leadership for a workshop on Communication Skills at DSI on January 10, 2013

Accomplishments

Received "Super Users" Award from Manager

  • Acknowledged for consistent and impactful contributions as a Super User within the team.
  • Recognized for dedication and effort in supporting team activities.
  • Appreciated for being a powerful and valuable member of the team.
  • Received accolades from management for outstanding performance and commitment.


"One Band One Sound" Award from Manager

  • Led team to enhance processes, delivering 150K+ ALCOA+ checks, 5K+ EDLs, and 2K+ completeness checks in therapeutic studies.
  • Contributed to team's multiple site-level awards, reflecting dedication to excellence.
  • Recognized for meeting stringent deadlines with unwavering commitment to quality.
  • Received "One Band One Sound" Award from Manager for outstanding contributions to team success.

RISE Award in Innovation

  • Recognized with the RISE award in the "INNOVATION" category for the creation of the TMF Idea Box in SharePoint.
  • Acknowledged for demonstrating curiosity, commitment, and dedication in developing a platform for new ideas and suggestions to enhance organizational processes.

Timeline

Specialist TMF Management

Eli Lilly services India private limited
08.2022 - Current

ETMF Quality Reviewer

Accenture Solutions Private
05.2020 - Current

M.Sc. in Biotechnology -

Maharani Lakshmi Ammanni College (MLAC)

B.Sc. - Chemistry Botany & Zoology

M.E.S. College

PUC (State Board) -

K.L.E. College

SSLC (State Board) - undefined

Haveri

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