TMF Lead II (Medtech)

Location: Must be based in Brazil, Mexico, Argentina, Colombia, Chile, or Peru

Company

hirify.global is a global organization dedicated to advancing clinical research and medical development.

What you will do

• Ensure timely and high-quality processing, review, and archival of study TMFs.
• Create and execute study TMF plans and document indexes.
• Collaborate with project managers and functional leads to maintain inspection-ready TMF states.
• Monitor TMF health metrics, identify risks, and implement mitigation strategies.
• Support audits and inspections, including participation in interviews.
• Manage study close-out activities and vendor eTMF system interactions.

Requirements

• Bachelor’s degree or equivalent international qualification.
• Minimum of 3 years of relevant experience in clinical research or TMF management.
• Professional working proficiency in English.
• Working knowledge of FDA and ICH/GCP regulations.
• Experience with eTMF systems and vendors.
• Strong organizational skills and ability to work independently in a remote environment.

Culture & Benefits

• Opportunity to build a new regional function within a growing LATAM team.
• Collaborative environment focused on professional development and clinical excellence.
• Commitment to equal opportunity and inclusive hiring practices.
• Supportive team structure with clear communication and professional standards.