Summary
Overview
Work History
Education
Skills
Certification
Cricket, Music, Guitar, Travelling
Timeline
Generic

Arun Bathoju

TMF Document Specialist
Hyderabad

Summary

Diligent TMF Document Specialist with more than 3 years of experience in ensuring compliance with regulatory standards and enhancing document quality. Skilled in Intelligent eTMF and Veeva Vault, I excel in teamwork and leadership, driving timely submissions and successful audits. Recognized for improving processes and maintaining high-quality trial master files. Experienced with managing and organizing comprehensive documentation systems. Skilled in utilizing TMF management systems including Wingspan, I-eTMF, Veeva Vault and various other platforms, possessing a comprehensive understanding of ICH-GCP guidelines, FDA regulations, and industry standards. Knowledge of collaborative techniques to support team efficiency and project success.

Overview

10
10
years of professional experience
4
4
Certifications
3
3
Languages

Work History

TMF Document Specialist

IQVIA
08.2024 - Current
  • Provide Trial Master File (TMF) related assistance to study teams.
  • Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices, and applicable regulatory requirements, and meets quality and timeline metrics.
  • Establish and maintain effective internal client communications.
  • Perform Wingspan/I-eTMF QC as per IQVIA SOP standards, and QC guidance documents.
  • Perform a Study Item List (SIL) review for selected studies as part of the File Review (FR) preparation and Action Items resolution raised by File Reviewers (if applicable).

TMF Specialist 1

IQVIA
05.2024 - 07.2024
  • Conduct the Comprehensive Quality Trial Master File Review in accordance with eSOPs, Guidance Documents, File Review Overview Form, and Project Instruction.
  • Liaise with document owners, TMF study owners, and/or other end users to resolve document-related discrepancies and issues.
  • Process documents in the TMF system(s) within specified timelines, based on document criticality and priority.
  • Support QPM in the timely delivery of the comprehensive file review cycle, proactively communicating the review finalization.
  • Coordinate with clinical operations teams, CROs, and vendors to ensure the timely submission and retrieval of essential trial documents.
  • Ensure the oversight of the collection, assessment, and structuring of trial-related documents to confirm adherence to ICH-GCP, FDA, and additional applicable regulatory guidelines.
  • Conduct a TMF Coherence review. This includes cross-checking and verifying the codependencies of the clinical trial documents contained within the Trial Master File (TMF), ensuring that the TMF is prepared for audits and inspections on eTMF platforms like Wingspan and Veeva Vault.
  • Conduct a quality review of TMF documents, coordinate with clinical operations teams, CROs, and vendors to guarantee the prompt submission and retrieval of critical trial documents.


Site File Associate 1

IQVIA
12.2021 - 04.2024
  • Skilled in the processes of capturing, managing, sharing, and storing critical documents and content from clinical trials within the electronic trial master file (eTMF).
  • Oversees the continuous renewals of IRB/ethics, as necessary, and examines investigator study files for any expired documents.
  • Engages with the local CRA and other stakeholders across different countries to secure amendments to incomplete, incorrect, or expired documents.
  • Monitor changes to the protocol and obtain IRB/ethics approvals for the amendments, as necessary.
  • Conduct evaluations of the designated collection of documents using the FR (File Review) tool.
  • Evaluates documents obtained from sites, IRBs, and CRAs to confirm adherence to GCP and IQVIA standard operating procedures.
  • Comply with the different departmental eSOPs, corporate policies, regulatory obligations, and the best practices of the company.


Drug Safety Associate

IQVIA
02.2021 - 11.2021
  • Improved patient safety by accurately reviewing and processing adverse event reports.
  • Collaborating with other departments, such as clinical research, regulatory affairs, and pharmacovigilance, to ensure compliance with safety regulations and guidelines.
  • Assisting in the preparation of safety reports to be submitted to regulatory agencies.
  • Responsible for processing the log workflow of ICSR into the database.
  • Acting as a bridge between the company and patients, or healthcare professionals, to deliver accurate information regarding product safety.

Pharmacist

Apollo Hospitals Enterprise Limited
08.2018 - 11.2019
  • Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
  • Provided pharmaceutical care to customers (e.g., processed and accurately dispensed prescription orders, counseled customers regarding health care and prescription medication needs).
  • Trained new pharmacy technicians, improving their performance, and built growth and sales through counseling and wellness programs that increased the revenue.
  • Provided customers with prompt and courteous service, and received 95% positive feedback in a customer satisfaction survey.
  • Ensuring whether a particular medication will interact with other medications used by the patient.

Junior ServiceNow Administrator

CNET Global Solutions Inc
02.2016 - 03.2017
  • Increased team productivity by creating custom dashboards, reports, and performance metrics in ServiceNow.
  • Involved in various ServiceNow customizations as per the client's requirements.
  • Implementations, customization, and maintenance of ITIL modules such as Incident Management, Change Management, Problem Management, Knowledge, and CMDB in ServiceNow.
  • Development of a service catalog, which includes creating new catalog items, designing workflows, and execution plans.
  • Worked on creating users, roles, groups, and configured the LDAP server and LDAP listener for updating the user and group table records.

Education

Master of Pharmacy - Pharmaceutical Sciences

Kakatiya University
Jangaon
04.2001 -

Master of Science - Computer Science

Northwestern Polytechnic University
Fremont, USA.
04.2001 -

Bachelor of Pharmacy - Pharmacy

Kakatiya University
Jangaon
04.2001 -

Skills

Intelligent ETMF, Wingspan

Veeva Vault

Teamwork and Leadership

MS Office, ServiceNow, Base SAS

Certification

ICH GCP Certification Exam

Cricket, Music, Guitar, Travelling

Team sports underscore collaboration, leadership, and resilience. Highlighting roles like “Team Captain” implies strategic thinking and conflict-resolution skills, aligning with management or dynamic work environments.

Achieving proficiency in an instrument necessitates discipline, creativity, and patience. It entails organized practice and accuracy—qualities that can be applied to analytical or detail-focused areas such as coding or project management.

Travel demonstrates flexibility, cultural sensitivity, and the ability to solve problems. It is particularly appealing for roles in international business or creative fields, highlighting a willingness to embrace various viewpoints

Timeline

TMF Document Specialist

IQVIA
08.2024 - Current

TMF Specialist 1

IQVIA
05.2024 - 07.2024

Site File Associate 1

IQVIA
12.2021 - 04.2024

Drug Safety Associate

IQVIA
02.2021 - 11.2021

Pharmacist

Apollo Hospitals Enterprise Limited
08.2018 - 11.2019

Junior ServiceNow Administrator

CNET Global Solutions Inc
02.2016 - 03.2017

Master of Pharmacy - Pharmaceutical Sciences

Kakatiya University
04.2001 -

Master of Science - Computer Science

Northwestern Polytechnic University
04.2001 -

Bachelor of Pharmacy - Pharmacy

Kakatiya University
04.2001 -

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Arun BathojuTMF Document Specialist