Precision Medicine Group has announced an exciting opportunity for the position of Quality Review Specialist in Bangalore, Karnataka. Professionals with experience in Trial Master File (TMF) Quality Reviews, eTMF systems, and knowledge of ICH-GCP regulations are encouraged to apply.
This role offers an excellent opportunity for clinical research and TMF professionals looking to advance their careers with a globally recognized organization focused on clinical development, regulatory excellence, and patient-centric healthcare solutions.
Job Overview
- Position: Quality Review Specialist
- Company: Precision Medicine Group
- Location: Bangalore, Karnataka, India
- Employment Type: Full-Time
- Experience Required: Minimum 2 Years
- Industry: Clinical Research, TMF Management, Quality Assurance
Key Responsibilities
The selected candidate will be responsible for ensuring Trial Master Files remain inspection-ready and compliant with regulatory standards.
Primary Duties
- Perform periodic TMF Quality Reviews for assigned clinical studies.
- Evaluate TMF completeness and compliance.
- Generate and file quality review documentation within the TMF.
- Monitor document processing issues and escalate discrepancies.
- Support updates to expected documents and TMF placeholders.
- Collaborate with TMF Leads and Functional Leads regarding missing documentation.
- Identify potential TMF training needs across study teams.
- Escalate serious quality risks affecting study readiness.
- Ensure consistent adherence to company SOPs and regulatory requirements.
Required Qualifications
Education
- Bachelor’s Degree or international equivalent.
Experience
- Minimum 2 years of relevant experience in TMF management, document quality review, or clinical operations.
Technical Skills
- Experience with eTMF systems and vendors.
- Strong proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
- Working knowledge of FDA regulations.
- Understanding of ICH-GCP guidelines and clinical trial documentation requirements.
Preferred Skills
Successful candidates should demonstrate:
- Strong attention to detail.
- Excellent organizational and time-management skills.
- Ability to work independently and within cross-functional teams.
- Strong written and verbal communication abilities.
- Effective issue identification and escalation capabilities.
- Commitment to quality and compliance.
Why Join Precision Medicine Group?
Precision Medicine Group is known for supporting innovation in clinical development and patient-focused healthcare solutions. Employees gain exposure to global clinical trials, advanced quality systems, and opportunities for professional growth in the clinical research industry.
Benefits May Include
- Competitive compensation package
- Career development opportunities
- Exposure to global clinical research projects
- Collaborative work environment
- Professional training and skill enhancement
How to Apply
