Trial Master File Associate Clinical Trials Manager (TMF ACTM) - Remote, US

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

This role maintains Trial Master Files for assigned studies under moderate supervision, participating in end-to-end TMF activities, including: adherence to organizational TMF standards and study-level
quality control reviews and facilitating issue resolution.

Responsibilities: 

• • Ensure TMF completeness and accuracy based on Vertex SOPs and regulatory requirements.
  • Maintain study-level TMFs including planning and setup, QC reviews, basic analysis, and vendor  oversight
  • Conduct content review of a variety of documents in a short time frame while maintaining  consistency and attention to detail
  • Prioritize work accordingly to meet departmental needs and work toward and meet deadlines with  moderate supervision
  • Generate metrics for department and study team usage supporting TMF completeness, accuracy  and quality
  • Participate in inspection readiness reviews and preparation activity
  • Provide training as applicable to TMF stakeholders
  • Participate in the onboarding of new staff
  • Participate in straightforward projects that may require cross-functional collaboration or involve coordinating system updates 

Qualifications:

• Bachelor's degree in relevant discipline
• 2 years of relevant work experience in a clinical development setting, or an equivalent combination of education and experience
• Experience with MS Excel, MS Project, MS PowerPoint, MS Word, SharePoint, eTMF,
• Detail orientated
• Strong Communication skills
• Possess good critical thinking skills with a focus on inspection readiness

To qualify for a role located in the U.S., applicants must be legally authorized to work in the United States and should not (now or in the future) require sponsorship for employment work visa status. 

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.