đ Build the Foundation of Clinical Trial Integrity
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, and medical device organizations. Our mission is to accelerate the development of therapies that improve patient lives.
We are seeking a meticulous TMF Specialist I to begin a specialized career in Trial Master File (TMF) management. This is an excellent entry-level opportunity to master the documentation that forms the regulatory backbone of every clinical trial. You will ensure compliance, organization, and quality within the TMF, directly supporting trial success and audit readiness.
đŻ YOUR MISSION: MASTER THE HEART OF TRIAL DOCUMENTATION
You will be responsible for learning and executing essential TMF document management activities. Your precision will ensure that critical trial documents are accurately filed, maintained, and ready for inspectionâa fundamental role in the clinical research process.
đ KEY RESPONSIBILITIES
đ TMF Process & Compliance
- Gain expertise in Trial Master File (TMF) documentation, structure, and document management processes.
- Ensure all activities comply with client-specific requirements and ICON standard operating procedures (SOPs).
- Contribute to client service contracts and internal business needs related to TMF management.
đď¸ Document Management & Quality
- Assist in the maintenance, organization, and quality control of TMF documentation in electronic systems (eTMF).
- Support the accurate filing and indexing of essential clinical trial documents to ensure inspection readiness.
- Collaborate with cross-functional study teams to facilitate timely and complete document submissions.
đ Cross-Functional Support
- Work effectively within a team environment, communicating clearly with colleagues and stakeholders.
- Participate in process improvements and training to build a strong foundation in TMF best practices.
đ¤ YOUR PROFILE
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ESSENTIAL REQUIREMENTS
- Bachelorâs degree in Life Sciences, Pharmacy, Health Information Management, or a related field.
- Strong attention to detail and exceptional organizational skills.
- Ability to follow procedures precisely and manage tasks efficiently in a team-based setting.
- Excellent written and verbal communication skills.
- Eagerness to build a career in clinical research documentation and compliance.
đ PREFERRED QUALIFICATIONS
- Prior exposure to clinical research, document management, or TMF processes through internships or academic projects.
- Familiarity with ICH-GCP guidelines and clinical trial documentation.
- Basic proficiency with electronic document management systems.
- A proactive learner with a commitment to quality and accuracy.
đź WHY START YOUR CAREER IN TMF AT ICON?
- Specialized Career Launchpad: Gain in-demand, niche expertise in TMF managementâa critical function in global clinical research.
- Structured Training: Receive comprehensive training in TMF processes, eTMF systems, and regulatory compliance.
- Global Impact:Â Your work ensures the integrity of trial data that leads to new medical treatments worldwide.
- Clear Growth Path: Progress to TMF Specialist II, Lead, or Manager roles within ICONâs global operations.
- Supportive Environment:Â Join a diverse, dynamic team that nurtures talent and rewards high performance.
đ READY TO BECOME A GUARDIAN OF TRIAL DOCUMENTATION?
đ APPLY NOW FOR THE TMF SPECIALIST I POSITION.
ICON is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We encourage all qualified applicants to applyâif you are detail-oriented and eager to begin a career in clinical research, we welcome your application.
