Meta Title:
TMF Specialist II – Clinical Research – ICON India
Meta Description:
Join ICON as a TMF Specialist II in India. Manage Trial Master Files, ensure compliance, and contribute to clinical research excellence.
Meta Keywords:
TMF Specialist II, ICON India, clinical research, Trial Master File, eTMF, ICH-GCP, regulatory compliance, clinical trials, document management, pharmaceutical jobs
Job Summary
ICON is seeking a dedicated TMF Specialist II to join our Clinical Trial Support team in India. In this role, you will oversee the management of Trial Master Files (TMF), ensuring compliance with regulatory standards and supporting the efficient execution of clinical trials. This position offers an excellent opportunity to contribute to the advancement of clinical research in a dynamic and supportive environment.
Key Responsibilities
TMF Management: Oversee the creation, maintenance, and quality control of TMF documents, ensuring compliance with ICH-GCP guidelines and regulatory requirements.
Documentation Support: Assist in the preparation and submission of TMF documents for audits and inspections.
Collaboration: Work closely with study teams, sponsors, and external partners to ensure timely and accurate documentation.
Training & Mentorship: Provide guidance and training to junior staff and team members on TMF processes and best practices.
Continuous Improvement: Identify opportunities for process enhancements and contribute to the development of TMF-related procedures.
Required Skills & Qualifications
Educational Background: Bachelor's degree in Life Sciences, Pharmacy, or a related field.
Experience: Minimum of 2 years in clinical research with a focus on TMF management.
Technical Proficiency: Familiarity with eTMF systems and document management tools.
Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and local regulatory requirements.
Communication Skills: Excellent verbal and written communication abilities.
Organizational Skills: Ability to manage multiple tasks and prioritize effectively.
Perks & Benefits
Competitive Salary: Attractive compensation package commensurate with experience.
Health Insurance: Comprehensive health coverage for you and your family.
Retirement Plans: Competitive retirement planning offerings.
Employee Assistance Program: Access to a global network of professionals for personal and professional support.
Work-Life Balance: Flexible working arrangements to support your personal commitments.
Professional Development: Opportunities for continuous learning and career advancement.
About ICON
ICON is a global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries. With a commitment to delivering high-quality services, ICON supports the development of new therapies and medical devices that improve the quality of life for patients worldwide.
Work Mode
This position is Office-Based in India, with potential for occasional travel as required by project needs.
Call to Action
If you are passionate about clinical research and possess the skills and experience outlined above, we encourage you to apply for the TMF Specialist II position at ICON. Join our team and contribute to the advancement of clinical trials that make a difference in patients' lives.
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Siliguri |Illinois :
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