Senior TMF Lead

Senior TMF LEAD - Remote - Mexico City

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

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 organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation 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.
What will you do:

• Ensure Trial Master File project specifications are in alignment with program strategies and milestones.
• Develop and assist with the implementation of the Trial Master File specifications i.e. Regulatory packet requirements, blinded vs. unblinded documentation, etc.
• Under supervision of TMF Owner Leadership, assist with responses to regulatory authorities with regard to documentation management activities for audits, questions and issues.
• Review data quality outputs and audit outputs to identify trends per study and across programs.
• Ensure consistent use of standardized processes and systems across all clinical trials and programs.
• Serve as point of contact for internal and external audits of study TMF-related queries.
• Analysis metrics and processes to actively identify continuous improvement opportunities and enhance operational efficiency.
• Provide support and guidance to the TMF Owner Group to drive performance against metric targets and resolve guidance conflicts and issues.
• Apply lessons learned for continuous improvement of documentation management practices across the TMF Owner group.
• Provide education, feedback and support to the TMF Owner Group and Doc. Mgmt. Team in order to build knowledge and awareness of good document management practices for clinical trials.
• Determine and review study specific TMF specifications to ensure quality is established and standardized across programs and kept up to date as programs/protocols progress.
• Assess the impact of potential changes to TMF specifications prior to implementation and collaborate with Sponsor Support Team if modifications are necessary.
• Review Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with TMF Owners and all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
• Support the preparation of appropriate audit and inspection responses.
• Enforce ownership and accountability across Study Teams regarding readiness of TMF documents.
• Support TMF Owners and Study Teams in addressing/reporting regulatory queries pertaining to document management.Support TMF Owners in resolving TMF content issues.
• Support TMF users in resolving filing issues and clarifying gaps in user understanding and available reference documents
• Facilitate communication and interaction among TMF Owners, Sponsors, Vendors, Internal departments and Study Team Members in matters regarding the TMF.
• Provide support and mentorship for new hires and other team members

What will you need:

• Must have more than 3 years of TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents.

• Ability to successfully liaise with study project teams, staff, clients and management, as necessary.

• Fluent English communication, writing and reading. 

• Experience as a Team Leader would be a plus

• Bachelor’s Degree in Life Science preferable

• Availability to work 3 times a week office based - Benito Juarez / Mexico City

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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.
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 through the form below.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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