TMF Specialist I at Allucent | Regulatory Affairs & Clinical Research Jobs
Looking for your next big step in regulatory affairs jobs or clinical research jobs? Join Allucent, a trusted global partner for biopharmaceutical innovation. As a TMF Specialist I, you’ll ensure high-quality documentation for clinical trials while growing your career in the fast-evolving world of life science careers. This hybrid position offers the chance to make a real impact by helping bring life-changing therapies to patients around the world.
About the Company:
Allucent™ is a global clinical research organization dedicated to advancing drug development and regulatory excellence. The company supports emerging and mid-sized biopharma clients in navigating complex clinical trials and global compliance requirements. At Allucent, innovation meets purpose — making it an ideal environment for professionals passionate about regulatory affairs jobs, clinical research jobs, and expanding their footprint in life science careers.
Job Overview:
The TMF Specialist I will play a vital role in managing Trial Master File (TMF) documentation and ensuring compliance with global regulatory affairs standards. You’ll oversee document accuracy, indexing, and metadata verification using Veeva Vault systems. This role is designed for professionals who aspire to strengthen their expertise in clinical research and data integrity
.- Location: Bengaluru, India (Hybrid)
- Job Type: Full-Time
Qualifications:
- Bachelor’s degree in Life Sciences, Healthcare, or a related discipline
- Minimum of 2 years of experience in clinical research or TMF documentation
- Strong understanding of GCP, GDP, and global regulatory affairs guidelines
- Excellent communication and organizational skills
- Proficiency in MS Office and familiarity with eTMF systems
Key Responsibilities:
- Review and approve documents in alignment with Good Document Practices (GDP) and ALCOA+ standards
- Ensure TMF files meet global regulatory affairs and clinical research compliance requirements
- Verify metadata and categorization within Veeva Vault
- Identify and resolve documentation inconsistencies
- Collaborate with cross-functional teams to maintain study documentation integrity
- Mentor junior TMF team members and support training within the life sciences department
Skills Required:
- Knowledge of clinical trial documentation and the DIA TMF Reference Model
- Familiarity with regulatory affairs jobs processes and submission standards
- Strong attention to detail, quality orientation, and time management
- Excellent written and verbal English communication skills
- Ability to thrive in fast-paced clinical research environments
If you’re driven to grow within regulatory affairs, clinical research, or broader life science careers, Allucent offers the perfect platform. Join a collaborative global team where your expertise in trial documentation and compliance contributes to accelerating the development of life-changing treatments.
How to Apply:
Interested candidates can apply directly via the Allucent Careers Portal for this position. Stay updated on future regulatory affairs and clinical research jobs across Allucent’s growing network.
