ICON plc is a global leader in healthcare intelligence and clinical research services. Renowned for its inclusive and innovative environment, ICON aims to drive excellence in clinical development. With a vision to advance and improve patients’ lives, ICON focuses on partnership, integrity, accountability, and delivery. If you’re passionate about making a difference in the healthcare industry, ICON is the ideal place to build your career.
Responsibilities in the TMF Specialist Job
As a TMF (Trial Master File) Specialist, you will play a pivotal role in supporting clinical studies and ensuring efficient document management. Your primary responsibilities include:
- Document Processing: Managing study documents per client and regulatory requirements. This includes document receipt, review, quality control, scanning, indexing, and archiving.
- Collaboration: Working closely with study teams, clients, and internal ICON teams to achieve project goals.
- Compliance: Ensuring adherence to ICON SOPs (Standard Operating Procedures), Work Procedures, and applicable regulations.
- Audits and Reporting: Participating in audits, preparing status reports, and maintaining compliance documentation.
- Training and Development: Engaging in training programs to enhance your knowledge and skills in TMF management.
- Special Projects: Handling additional duties or projects as assigned by the Manager.
Qualifications Required
To qualify for the TMF Specialist role, candidates should meet the following criteria:
- Educational Background: A Bachelor’s degree in Life Sciences is preferred.
- Experience: 1-15 years of experience in TMF management with a solid understanding of clinical study documents.
- Skills: Strong oral and written communication skills, excellent interpersonal abilities, and familiarity with clinical research processes.
Skills and Attributes
- Attention to Detail: High level of accuracy in managing and reviewing critical documents.
- Team Collaboration: Ability to liaise effectively with project teams, clients, and management.
- Time Management: Strong organizational skills to handle multiple tasks and meet deadlines.
- Regulatory Knowledge: Familiarity with clinical trial regulations and documentation standards.
Why Join ICON?
ICON offers a dynamic work environment, competitive compensation, and opportunities for career growth. Key benefits include:
- Competitive salary packages and performance-based bonuses.
- Comprehensive health and retirement plans.
- Flexible benefits tailored to your personal and family needs.
- Employee Assistance Program for wellness support.
- Recognition programs to reward high performance.
