TMF Classifier Job at in Bangalore at Fortrea for clinical research professionals with eTMF GCP knowledge hybrid role apply before March 25 deadline
Company Overview
Fortrea is a well-established Contract Research Organization (CRO) delivering clinical development and data solutions to pharmaceutical, biotechnology, and medical device companies worldwide. With a strong focus on clinical operations and regulatory compliance, Fortrea supports global clinical trials through advanced systems and expert-driven processes.
The organization offers a collaborative environment where professionals can build expertise in clinical documentation, regulatory standards, and trial management systems.
Job Location & Employment Type
- Location: Bangalore
- Work Mode: Hybrid
- Employment Type: Full-Time
Open Positions / Department Details
- Position: TMF Classifier II
- Department: Clinical Operations / Trial Master File (TMF)
This role is focused on managing electronic Trial Master Files (eTMF) and ensuring documentation compliance as per global regulatory standards.
📊 Job Overview (Quick Details)
| Job Title | TMF Classifier II |
|---|---|
| Company | Fortrea |
| Location | Bangalore (Hybrid) |
| Employment Type | Full-Time |
| Department | Clinical Operations / eTMF |
| Experience Required | 1 – 2 Years |
| Qualification | B.Pharm / M.Pharm / Pharm.D / BSc / MSc / Life Sciences / Business |
| Salary | ₹4.5 – ₹7 LPA (Estimated) |
| Mode of Application | Online |
| Last Date | March 25, 2026 |
Key Roles & Responsibilities
The selected candidate will be responsible for handling clinical trial documentation and maintaining compliance within eTMF systems. Key responsibilities include:
- Manage electronic Trial Master Files (eTMF) across trial, country, and site levels.
- Perform document classification activities within Smart Inbox and support ARC review workflows.
- Handle document lifecycle activities including classification, tracking, and deletion.
- Conduct quality checks to ensure documents are clear, complete, and accurate before final submission.
- Perform audit-ready checks to maintain documentation standards at all times.
- Ensure compliance with ICH-GCP guidelines, sponsor SOPs, and internal quality processes.
- Track essential clinical documents throughout all study phases.
- Identify and resolve issues related to TMF operations and documentation workflows.
- Prepare documentation for QA and sponsor audits and support audit activities.
- Implement corrective and preventive actions (CAPA) based on audit findings.
- Collaborate with study teams, sponsors, and clinical operations teams for smooth execution.
- Participate in process improvement initiatives to enhance efficiency and quality.
- Provide training and knowledge-sharing support when required.
Eligibility Criteria
🎓 Education
Candidates must have one of the following qualifications:
- B.Pharm / M.Pharm / Pharm.D
- BSc / MSc (Life Sciences)
- Degree in Business or related field
💼 Experience
- Minimum 1–2 years of experience in clinical research or TMF management
- Hands-on experience with eTMF systems or clinical documentation is preferred
🛠 Skills Required
- Strong understanding of ICH-GCP guidelines and regulatory requirements
- Knowledge of clinical trial documentation and compliance processes
- Experience with eTMF platforms (e.g., Veeva Vault or similar systems)
- Proficiency in Microsoft Office and Adobe Acrobat tools
- Attention to detail and strong organizational skills
- Good communication and interpersonal abilities
- Ability to work collaboratively in cross-functional teams
- Problem-solving mindset with the ability to manage multiple tasks
Salary & Benefits
- Estimated Salary: ₹4.5 LPA – ₹7 LPA
- Hybrid working flexibility
- Opportunity to work on global clinical trials
- Exposure to regulatory compliance and audit processes
- Career growth in clinical operations, TMF, and regulatory domains
- Learning opportunities through training and mentoring programs
Selection Process
The recruitment process generally includes:
- Online application submission
- Resume screening
- Technical interview (clinical research & TMF knowledge)
- HR discussion
- Final selection
How to Apply
Interested candidates can apply through the official online application link provided by Fortrea.
- Ensure your resume highlights your clinical research and eTMF experience
- Mention any exposure to audit support or regulatory documentation
Important Dates
- Last Date to Apply: March 25, 2026
Why Apply for This Pharma Job?
This opportunity is ideal for professionals aiming to build a strong career in clinical documentation and Trial Master File management. Working with Fortrea allows candidates to gain hands-on experience in global clinical trials, audit processes, and regulatory compliance.
The role provides excellent exposure to eTMF systems and collaboration with international teams, making it a valuable step toward advanced roles in clinical operations and regulatory affairs.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with any company. We do not charge any fees for job applications. Candidates are advised to verify job details from the official website before applying.
Final Call-to-Action
If you have experience in clinical research and want to grow in the eTMF and regulatory domain, apply now before the deadline and secure your position.
