As a Senior TMF Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be joining one of our integral pharmaceutical clients; a prestigious organization, specializing in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
**What you will be doing**:
- The role independently maintains the Trial Master Files for assigned studies, participating in end-to-end TMF management activities, including adherence to organizational TMF standards and study-level quality control reviews, and facilitating issue resolution.
- Ensure TMF completeness and accuracy based client´s SOPs and regulatory requirements
- Maintain study-level TMFs including QC review, analysis, and vendor oversight (if applicable)
- 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 some supervision
- Generate metrics for department and study team usage supporting TMF completeness, timeliness and quality
- Participate in inspection readiness reviews,



preparation activity and inspection conduct
- Provide guidance and training as applicable to TMF stakeholders; serve as a resource to colleagues on more advanced TMF activities
- Coordinate onboarding of new staff
- Participate in and may lead projects that require cross-functional collaboration or involve coordinating system updates
**You are**:
- Bachelors degree in relevant discipline
- Strong verbal/written communication, presentation skills and interpersonal skills to educate/train project teams and other stakeholders and exchange key information
- Effectively communicates and coordinates activities within the group and other TMF stakeholders
- MS Excel, Word, PowerPoint expertise
- Experience working in a TMF platform
- Experience working in a CTMS platform
- Possess strong critical thinking skills with a focus on inspection readiness
**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

📌 Senior Tmf Lead (México)
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📍 México