Manager, Records Management (LATAM)

TL;DR

Manager, Records Management (LATAM): Building and leading a regional team of clinical document specialists to ensure high-quality Trial Master File (TMF) management with an accent on regulatory compliance and process standardization. Focus on overseeing document quality, mentoring staff, and driving efficiency across clinical programs in the LATAM region.

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

Company

hirify.global is a global clinical research organization dedicated to accelerating the development of new therapies through specialized clinical solutions.

What you will do

• Oversee staff performing TMF-related activities, including document quality review and study-level engagement.
• Ensure alignment of team activities with study-specific requirements and TMF plans.
• Provide leadership, training, and performance management to a team of document and quality review specialists.
• Identify systemic quality issues and implement mitigation strategies to ensure compliance with GCP and regulatory standards.
• Collaborate with leadership to drive process improvement initiatives and develop SOPs.
• Support business development activities, including proposal responses and bid defense meetings.

Requirements

• Bachelor’s degree or international equivalent.
• Minimum 8 years of related experience, including at least 2 years in a leadership capacity.
• Professional working proficiency in English.
• Working knowledge of FDA and ICH/GCP regulations.
• Experience with eTMF systems and vendors.
• Strong organizational, communication, and problem-solving skills.

Culture & Benefits

• Opportunity to build and shape a regional team in LATAM.
• Commitment to professional development and performance excellence.
• Collaborative environment focused on clinical innovation and quality.
• Equal opportunity employer with a focus on inclusive hiring practices.