TMF Lead

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The Trial Master File Lead will play a key role in developing and assisting with the implementation of TMF specifications, ensuring they are in alignment with the program strategy and milestones. Assess the impact of potential changes to TMF specifications prior to implementation and collaborate with Sponsor Teams as appropriate. Serve as the single point of contact for functional team members and clients related to TMF processes and activities.

Under the supervision of the TMF Operations Leadership team, the Trial Master File Owner/Lead will assist with responses to regulatory authorities/inspectors with regard to documentation management activities for audits, questions, and issues. The Trial Master File Lead will regularly review metrics established for performance, review data quality outputs and audit outputs to identify trends per study and across programs, and assist with the development of corrective action plans related to TMF findings. The Trial Master File Lead will review the processes to actively identify continuous improvement opportunities and enhance operational efficiency. Working in a professional and employee friendly environment, the TMF Lead will frequently communicate within both internal and external clients in a professional manner.

To succeed you will need:

• Bachelor's Degree is required along with a minimum of 7+ years of Clinical Operations/Documentation Management/Clinical Research industry experience.
• You will require TMF and industry experience to understand the processes and documents required within the conduct of clinical trials.
• You will have good organizational and negotiation skills, the ability to manage multiple tasks and proven experience of high standards of attention to detail.
• You will possess good written and verbal communication skills with global projects/team exposure. Project Management and Quality Assurance experience will be an added advantage
• Competent computer skills - MS Outlook, PPT, Excel and experience with electronic document management systems preferred.

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.