Are you an experienced Trial Master File (TMF) professional looking to elevate your career in the clinical research industry? OrciMed Life Sciences is currently hiring TMF Specialists to join its growing team in Hyderabad, one of India’s leading hubs for pharmaceutical and life sciences innovation.
If you have strong expertise in clinical documentation, regulatory compliance, and eTMF systems, this opportunity could be the perfect next step in your professional journey. 🌟
About OrciMed Life Sciences 🧬
OrciMed Life Sciences is a rapidly growing organization in the clinical research and pharmacovigilance sector. The company partners with global pharmaceutical and biotechnology companies to support the development of safe and effective medicines.
The organization focuses on three core values:
- Transparency
- High Quality Standards
- Continuous Innovation
Employees at OrciMed benefit from a collaborative environment where clinical experts, regulatory specialists, and data professionals work together to deliver high-quality clinical services.
Job Role: TMF Specialist 📄
As a TMF Specialist, you will play a crucial role in maintaining the integrity and compliance of clinical trial documentation.
Your primary responsibility will be ensuring that the Trial Master File (TMF) is complete, accurate, and ready for regulatory inspections at all times.
Key Responsibilities 🔍
1. Documentation Management
- Manage the lifecycle of clinical trial documents from setup to archival.
2. Quality Control
- Perform quality checks to ensure documents comply with SOPs, ICH-GCP guidelines, and regulatory standards.
3. eTMF System Handling
- Utilize the Phlex TMF platform to organize, track, and manage clinical trial documentation.
4. Team Collaboration
- Coordinate with Clinical Trial Teams (CTTs) to resolve document discrepancies and missing records.
5. Audit & Inspection Preparation
- Support audit readiness and regulatory inspections by ensuring documentation completeness.
Eligibility Criteria 🎓
Candidates interested in this role should meet the following requirements:
- Experience: Minimum 2+ years of TMF experience
- Platform Expertise: Hands-on experience with Phlex TMF (mandatory)
- Education: Degree in Life Sciences, Pharmacy, or related field
- Availability: Immediate joiners or candidates with a short notice period preferred
Work Location: Hyderabad – India’s Life Sciences Hub 🏢
Hyderabad has become a global center for pharmaceutical research, biotechnology, and vaccine manufacturing. Often referred to as the “Vaccine Capital of the World,” the city hosts numerous multinational pharma companies and research organizations.
Working in Hyderabad offers:
- Access to a thriving biotech ecosystem
- Opportunities to collaborate with global pharmaceutical companies
- A vibrant lifestyle with modern infrastructure and cultural heritage
How to Apply 📧
Interested candidates can apply by following these simple steps:
Step 1: Update your CV highlighting your TMF experience and Phlex TMF skills
Step 2: Send your updated CV to:
📩 careers@orcimedlifesciences.com
Apply soon and become part of a company committed to advancing the future of healthcare.