TMF Specialist I at Allucent – Apply Now

Are you passionate about ensuring clinical trial quality and documentation integrity?
Allucent, a global clinical research organization helping small and mid-sized biopharma companies accelerate drug development, is hiring a TMF Specialist I in Bengaluru, India (Hybrid).

This full-time opportunity is ideal for candidates with experience in Trial Master File (TMF) management, Good Clinical Practice (GCP) compliance, and clinical documentation systems like Veeva Vault.

Key Responsibilities

As a TMF Specialist I at Allucent, your primary responsibilities include:

• Reviewing documents for compliance with Good Documentation Practices and ALCOA+ standards.
• Categorizing and indexing documents according to the DIA TMF Reference Model and Allucent TMF Index.
• Verifying metadata consistency in Veeva Vault.
• Assessing document quality and returning noncompliant items for correction.
• Identifying trends in documentation issues and escalating as necessary.
• Participating in TMF team meetings and supporting continuous improvement.
• Mentoring junior TMF staff.
• Supporting process enhancement within the Quality Management System (QMS).
• Collaborating with clients and participating in evaluations or audits.

Qualifications and Requirements

To be successful in this role, you should have:

• A degree in Life Sciences, Healthcare, or Business.
• Minimum 2 years of experience in TMF document processing.
• At least 2 years of experience in clinical research or drug development.
• Strong knowledge of GCP, GDPR/HIPAA, CRF, and CTR regulations.
• Familiarity with DIA TMF Reference Model and clinical trial documentation.
• Excellent English communication skills, attention to detail, and administrative accuracy.
• Proficiency in MS Word, Excel, and PowerPoint.
• A proactive, client-focused mindset with the ability to thrive in a fast-paced environment.

Benefits at Allucent

Working at Allucent comes with several perks:

• Competitive salary and comprehensive benefits package.
• Flexible working hours and hybrid setup.
• Training budget and access to professional development platforms.
• Leadership and mentoring opportunities.
• Recognition through Spot Bonus and Loyalty Award programs.
• Access to internal growth opportunities and the Buddy Program.

How to Apply

Application Link