Senior Document Management Associate
Senior Document Management Associate
Novotech
Job description
Looking to build a career in clinical trial documentation and TMF management? Explore this Senior Document Management Associate role at Novotech in Bangalore.
Company Description
Novotech is a known Contract Research Organization. It offers trial management, regulatory support and scientific advisory services all over the world. The company works in Asia Pacific, Europe and the United States. Novotech is very skilled in operations and in keeping documentation compliant. It holds ISO 27001 and 9001 certificates showing a commitment to quality. Novotech continues to support pharma and biotech clients through every phase of a trial.
Job Summary
This role supports Trial Master File (TMF) activities for teams on global projects. As a Senior Document Management Associate you will handle both paper and electronic TMFs while following ICH guidelines and other regulatory rules. Your tasks will include quality control reviews, audit readiness checks and help with study closeout. You will also mentor team members and keep documentation practices strong on every project.
Key Responsibilities
Manage paper and electronic Trial Master Files for assigned studies.
Perform detailed quality control reviews on crucial clinical trial documents.
Check documents for completeness, legibility and correct indexing.
Monitor TMF completeness metrics and conduct regular reviews.
Prepare trial files for inspections and client audits.
Apply DIA TMF Reference Model standards to keep documents organized.
Track query resolution times and report documentation gaps to management.
Prepare TMF exports and support archiving during study closeout.
Mentor and train Document Management Associates on TMF processes.
Coordinate with Clinical Research Associates and study teams to resolve missing documents.
Ensure that all documents are filed properly so the TMF is always prepared for inspection.
Educational Qualification
Bachelor's or Master's degree in Life Sciences or Pharmacy.
Skills Required
At two years of hands‑on experience in TMF or eTMF management at a CRO or in pharma.
Have an understanding of ICH guidelines and regulatory documentation standards.
Experience with eTMF systems, such, as Veeva Vault TMF.
Good knowledge of MS Office tools.
Excellent organizational skills and close attention to detail.
Clear communication skills to work with teams.
Solid understanding of audit and inspection readiness practices.
Salary Structure
The average salary for a Senior Document Management Associate at Novotech in India ranges from ₹6 Lakhs to ₹7 Lakhs per year.
Career Development
This role offers leadership experience in clinical documentation at a respected global CRO. Novotech supports long‑term growth with work options, wellness programs and continuous professional development opportunities.
How to Apply
Visit our job portal and search for the Senior Document Management Associate role - Novotech.
Click on the job listing to read all the details, about the job.
Fill in your information. Upload your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
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.