Leading global clinical research organization ICON plc is hiring for TMF Specialist I and Senior TMF Specialist positions in India. These exciting clinical research opportunities are available in Chennai and Bangalore for professionals interested in Trial Master File (TMF) management, clinical documentation, and regulatory compliance.
Candidates with backgrounds in life sciences, pharmacy, biotechnology, clinical research, or related disciplines can explore these opportunities to build a rewarding career in the clinical trials industry.
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to helping pharmaceutical, biotechnology, and medical device companies accelerate the development of innovative medicines and treatments. The company operates across multiple countries and supports clinical trials from early development through commercialization.
TMF Specialist I โ Chennai, India
Job Location
Chennai, Tamil Nadu, India
Employment Type
Full-Time
Work Model
Office With Flex
Key Responsibilities
- Gain familiarity with Trial Master File (TMF) documentation and document management processes.
- Support client services contracts and internal TMF management activities.
- Ensure compliance with client requirements and ICON procedures.
- Maintain and organize TMF documentation.
- Collaborate with cross-functional teams to ensure timely filing of essential clinical trial documents.
- Support document quality and completeness throughout the study lifecycle.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related field.
- Prior experience in clinical research or document management is preferred.
- Strong organizational and documentation skills.
- Excellent attention to detail.
- Good communication and teamwork abilities.
Preferred Skills
- Understanding of clinical trial documentation.
- Knowledge of GCP and regulatory requirements.
- Experience working with electronic document management systems is advantageous.
Senior TMF Specialist โ Chennai & Bangalore
Job Locations
- Chennai, Tamil Nadu, India
- Bangalore, Karnataka, India
Employment Type
Full-Time
Work Model
Office With Flex
Key Responsibilities
- Manage and maintain the Trial Master File (TMF) for assigned clinical trials.
- Ensure TMF completeness, accuracy, and quality throughout the study lifecycle.
- Coordinate with study teams for timely collection and filing of essential documents.
- Conduct TMF audits and inspection readiness activities.
- Ensure compliance with regulatory requirements and sponsor expectations.
- Provide TMF-related guidance and support to internal stakeholders.
Qualifications
- Bachelor’s degree in a scientific or related discipline.
- Advanced degree preferred.
- Minimum 3 years of experience in clinical research or TMF management.
- Strong knowledge of TMF regulations, guidelines, and industry best practices.
- Experience with electronic TMF systems and document management platforms.
- Excellent communication, organizational, and problem-solving skills.
Preferred Skills
- TMF audit readiness expertise.
- Inspection support experience.
- Strong understanding of ICH-GCP requirements.
- Experience managing multiple clinical studies.
Why Join ICON?
ICON offers a comprehensive employee benefits package including:
- Competitive salary and performance incentives.
- Health and wellness programs.
- Medical, dental, and vision benefits (where applicable).
- Retirement and pension plans.
- Life insurance and disability coverage.
- Employee assistance programs.
- Learning and development opportunities.
- Global clinical research career growth pathways.
Who Should Apply?
These positions are ideal for:
- B.Pharm graduates
- M.Pharm graduates
- Pharm.D professionals
- Life Sciences graduates
- Biotechnology graduates
- Clinical Research professionals
- TMF Specialists
- Clinical Trial Documentation professionals
- Regulatory and Quality Documentation professionals
How to Apply
Application Link For TMF Specialist I โ Chennai, India
Application Link For Senior TMF Specialist โ Chennai & Bangalore
