Trial Master File Associate
Trial Master File Associate
Takeda
Job description
Takeda is hiring a TMF Associate for its TMF Center of Excellence in Bengaluru, offering a great career opportunity for science graduates with 1 year of experience in clinical research or document management.
Company Description
Takeda is a global drug company that keeps patients at the center of everything it does. The company values are integrity, fairness, honesty, and perseverance. It works toward better health and a brighter future for people worldwide by creating ideas in medicine. Takeda is an opportunity employer. Every person can make an impact.
Job Summary
This is a full-time role for a TMF Associate in the TMF Center of Excellence, based in Bengaluru. The person will process, sort, index, and keep eTMF study documents and will carry out second-level quality checks. The role supports trial delivery and pharmacovigilance records and helps keep records ready for inspections worldwide. Candidates need 1 or more years of experience.
Key Responsibilities
Process, classify, index, and maintain eTMF study documents as per SOPs, rules, and study needs.
Carry out second-level quality checks so records are complete, accurate, and consistent.
Find record quality risks and metadata mistakes, and help fix them on time.
Keep reports and tracking tools up to date for visibility and control.
Support smooth record workflows, from intake and review to approval, filing, storage, and archiving.
Make workflows simpler and more standard, and cut down steps.
Help bring in automation and templated solutions to improve quality.
Work with teams to settle questions fix issues and give support.
Add to reports and dashboards that help improve work and oversight.
Raise record issues, compliance risks, and workflow problems through the channels.
Help write process papers, training material, and inspection readiness support.
Educational Qualification
A science, allied health, or medical degree, such as B. Sc or BA, is needed, or equivalent experience.
Candidates should have 1 or more years of experience in clinical research, TMF work, or document management.
Skills Required
Knowledge of TMF management, compliance, and inspection readiness.
Experience with Veeva Vault eTMF is preferred.
Knowledge of rules such as ICH E6, 21 CFR Part 11, EU CTR, and EU GVP.
Understanding of ALCOA+ data integrity and Good Documentation Practices.
Understanding of the DIA TMF Reference Model, TMF plans, and risk-based TMF quality checks.
Clear written, spoken, and people skills.
Good use of Microsoft Office, automation tools, and digital workflow tools.
Salary Structure
The salary for a TMF Associate (Trial Master File Associate) in the TMF Center of Excellence at Takeda in Bengaluru typically ranges from ₹6 Lakhs to ₹11 Lakhs per year.
Career Development
This role builds skills in TMF management, records quality, and inspection readiness at a global pharma company. This role can help you grow into a TMF associate, a TMF specialist, or other wider clinical documentation roles over time.
How to Apply
Visit our job portal and search for the TMF Associate role at Takeda in Bengaluru.
Click on the job posting to explore all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.