- Location
- India, Chennai
- Workplace
- Onsite
- Type
- Full-time
- Experience
- 3+ years
- Education
- Bachelor
- Visa
- Not sponsored
- Source
- Workday
Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a TMF Specialist at ICON, you will manage the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
Your experience in trial master file management will be key in delivering high-quality outcomes and mentoring colleagues.
Key responsibilities include:
- Managing and maintaining the Trial Master File (TMF) for assigned clinical trials.
- Ensuring the completeness, accuracy, and quality of TMF documents throughout the trial lifecycle.
- Collaborating with study teams to ensure timely collection, processing, and filing of essential documents.
- Conducting TMF audits and inspections to ensure compliance with regulatory standards and sponsor requirements.
- Providing support and guidance on TMF-related matters to internal stakeholders.
Your Profile:
You will have a strong foundation in trial master file management, with the experience to work independently and guide others.
Required qualifications and experience:
- Bachelor's degree in life sciences, documentation management, or a related discipline
- Minimum of 3 years of experience in clinical research or TMF management.
- Strong understanding of TMF regulations, guidelines, and best practices.
- Proficiency in electronic document management systems and TMF software.
- Excellent organizational, communication, and attention to detail skills.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
