Be the Guardian of Clinical Trial Integrity
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our 'Own It' culture—driven by Accountability, Collaboration, Partnership, and Integrity—enables us to advance and improve patients' lives as the partner of choice in drug development.
We are seeking a meticulous TMF Specialist to join our team in Chennai. In this vital role, you will be responsible for the accurate and compliant management of the Trial Master File (TMF), the definitive record of a clinical trial's conduct. Your attention to detail will ensure regulatory inspection readiness and support the success of global clinical research.
Your Role: Ensure Documentation Excellence
As a TMF Specialist, you will perform essential document management activities in support of client contracts and ICON's business needs, ensuring all trial documentation is processed, filed, and maintained to the highest standards.
Key Responsibilities:
Core Document Management:
- Process and manage clinical trial documents in accordance with study-specific processes, ICON SOPs, ICH-GCP, and regulatory requirements.
- Complete activities related to document receipt, review, scanning, indexing, quality control, and archival.
- Maintain study files (both electronic and paper-based) as per client and regulatory standards.
Collaboration & Quality Assurance:
- Liaise effectively with study teams, other TMF staff, and clients to fulfill responsibilities and resolve queries.
- Provide information for client and departmental status reports.
- Participate in client and internal audits and support archiving activities as necessary.
Process & Project Support:
- Complete assigned departmental projects within specified timelines.
- Inform management of training needs, project activities, quality issues, and timelines.
- Handle special projects and duties as requested.
Your Profile: What You Need
Experience & Skills:
- 1-15 years of direct, hands-on experience in TMF (Trial Master File) management within a CRO, pharmaceutical, or clinical research setting.
- Strong knowledge of clinical study documents and the TMF reference model.
- Ability to successfully liaise with project teams, staff, clients, and management.
- Excellent organizational skills and unwavering attention to detail.
- Good oral and written communication skills in English.
Education:
- Bachelor's Degree in Life Science (Pharmacy, Biology, Biotechnology, etc.) is preferred.
Why Join ICON in Chennai?
Our 'Own It' Culture:
You'll work in a dynamic, supportive environment with some of the brightest minds in the sector, helping to shape the industry while fulfilling your sense of purpose.
Career Growth & Benefits:
- Clear Career Progression: Ongoing development with opportunities to move into related areas and enhance your skill set.
- Very Competitive Salary & Bonus: Performance-driven annual bonus reflecting shared goals.
- Comprehensive Benefits: Health coverage, paid time off, income protection, and retirement plans.
- Global Support: Access to a Global Employee Assistance Programme and wellbeing initiatives.
- Inclusive Employer: ICON is an equal opportunity employer committed to a diverse and harassment-free workplace.
Ready to ensure the documentation excellence that underpins successful clinical trials?
Apply now for the TMF Specialist position in Chennai.
We encourage all qualified candidates to apply. If you require a reasonable accommodation during the application process, please let us know.
