TMF Reviewer I Job at Fortrea in Bangalore for clinical research professionals with eTMF experience apply online and grow career globally
Are you looking to advance your career in clinical research documentation and Trial Master File (TMF) management? Fortrea is currently offering an excellent opportunity for experienced professionals to join as a TMF Reviewer I in Bangalore. This role is ideal for candidates with strong expertise in eTMF systems, regulatory compliance, and clinical trial documentation who want to work in a globally recognized CRO environment.
This position provides a chance to contribute to high-quality clinical research projects while gaining exposure to international regulatory standards and audit processes. TMF Reviewer I Job at Fortrea
Company Overview
Fortrea is a globally recognized contract research organization (CRO) that supports pharmaceutical, biotechnology, and healthcare companies in conducting clinical trials and drug development programs. The organization focuses on delivering high-quality research solutions while maintaining strict compliance with international standards. With its strong global presence and expertise in clinical operations, Fortrea provides professionals with opportunities to work on complex studies and build long-term careers in clinical research. TMF Reviewer I Job at Fortrea
Job Overview
| Job Title | TMF Reviewer I |
|---|---|
| Company | Fortrea |
| Location | Bangalore |
| Work Mode | Hybrid |
| Industry | Clinical Research / CRO |
| Experience Required | 4 – 10 Years |
| Qualification | B.Pharm / M.Pharm / Pharm.D / B.Sc / M.Sc (Life Sciences) |
| Employment Type | Full-Time |
| Salary | As per company norms |
| Application Mode | Online Application |
Job Location & Employment Type
- Location: Bangalore
- Work Model: Hybrid (office + remote flexibility)
- Job Type: Full-Time
Open Positions / Department Details
- Department: Clinical Operations / TMF Management
- Role Type: TMF Review & Compliance Specialist
- Focus Area: Electronic Trial Master File (eTMF) management and regulatory documentation
Key Roles & Responsibilities
TMF Review & Document Management
- Review electronic Trial Master Files (eTMF) at trial, country, and site levels
- Ensure proper classification and indexing of clinical documents
- Perform ARC (Accuracy, Relevance, Completeness) checks where applicable
- Maintain alignment between sponsor TMF index and internal systems
Compliance & Quality Assurance
- Ensure all TMF documents meet audit readiness standards
- Conduct quality checks for document clarity, completeness, and correctness
- Maintain compliance with GCP, ICH, and regulatory guidelines
- Monitor adherence to SOPs and regulatory requirements
Audit & Inspection Support
- Prepare TMF documentation for internal and sponsor audits
- Support audit findings resolution and implement corrective actions
- Participate in internal and external audit processes
System & Process Management
- Work with eTMF platforms and document management systems
- Track essential documents across different stages of clinical trials
- Identify and resolve operational challenges related to TMF
Collaboration & Training
- Collaborate with study teams, project members, and quality teams
- Participate in study meetings and stakeholder discussions
- Provide training and mentoring support to junior team members
- Contribute to continuous improvement initiatives
TMF Reviewer I Job at Fortrea
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in:
- Pharmacy (B.Pharm / M.Pharm / Pharm.D)
- Life Sciences (B.Sc / M.Sc)
- Related discipline
Experience
- 4 to 10 years of experience in clinical research
- Hands-on experience in:
- TMF management
- Clinical documentation
- eTMF systems
Skills Required
- Strong knowledge of GCP and ICH guidelines
- Understanding of regulatory and clinical documentation requirements
- Proficiency in:
- MS Office tools
- Adobe Acrobat
- eTMF platforms and clinical systems
- Strong analytical and organizational abilities
- Excellent communication and teamwork skills
TMF Reviewer I Job at Fortrea
Salary & Benefits
- Salary: As per company norms
- Performance-based incentives (if applicable)
- Health and wellness benefits
- Opportunity to work in a global CRO environment
- Exposure to international clinical research standards
- Career growth and learning opportunities
Selection Process
The selection process may include: TMF Reviewer I Job at Fortrea
- Resume screening based on relevant TMF and clinical research experience
- Technical interview focusing on TMF processes, GCP, and documentation
- HR discussion for role alignment and compensation
- Final selection and onboarding
How to Apply
- Interested candidates can apply through the official online application link
- Ensure your resume highlights:
- TMF review and eTMF experience
- Clinical documentation expertise
- Regulatory compliance knowledge
Important Dates
- Application Deadline: Not specified (apply early to avoid missing the opportunity)
Why Apply for This Pharma Job?
This role is an excellent opportunity for clinical research professionals who want to specialize in TMF management and regulatory documentation. Working with Fortrea allows candidates to gain exposure to global clinical trials, audit processes, and international compliance standards. The hybrid work model adds flexibility, while Bangalore offers a strong ecosystem for career growth in clinical research.
Professionals in this role can enhance their expertise in quality systems, audit readiness, and sponsor collaboration, which are highly valued skills in the CRO and pharmaceutical industries. TMF Reviewer I Job at Fortrea
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Fortrea or any other organization mentioned above. We provide job-related information for educational and informational purposes only. Candidates are advised to verify all details through the official website before applying. We do not charge any fees for job applications. TMF Reviewer I Job at Fortrea
Final Call-to-Action
If you have relevant experience in clinical research, TMF management, and regulatory documentation, this is a great opportunity to advance your career. Apply now and take the next step toward working with a globally recognized clinical research organization. TMF Reviewer I Job at Fortrea
