Manager, Records Management (LATAM)

As part of an exciting expansion across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, we are seeking a talented and experienced Manager of Records Management to build and lead our growing Clinical Systems team in the LATAM region. This is a high-impact leadership role at the intersection of clinical operations, quality management, and team development — ideal for a seasoned professional ready to shape the future of Trial Master File (TMF) management across a dynamic and growing portfolio.

In this role, you will oversee a team of Documents Specialists, Quality Review Specialists, and TMF Leads, ensuring the quality and compliance of study-specific Trial Master Files across a broad range of clinical programs. You will serve as a subject matter expert, a people leader, and a strategic partner to cross-functional stakeholders — all while driving continuous process improvement and operational excellence within Clinical Solutions.

• Oversee staff performing TMF-related activities, including document quality review and processing, TMF quality reviews, and study-level engagement to ensure proper filing of essential clinical study documents
• Review study TMF Plans and TMF Document Indexes to confirm alignment of staff activities with study-specific requirements
• Assist in addressing cross-functional questions related to TMF management and study-specific documentation alignment
• Ensure proper execution of role-specific activities and oversee the quality of TMF support delivered by Documents Specialists, Quality Review Specialists, and TMF Leads
• Complete periodic and random quality and completeness checks of work performed by team members
• Review TMF metrics via system reports and dashboards, identifying process and staff performance challenges
• Ensure all required TMF-related documentation is filed in the eTMF in a timely and compliant manner
• Identify systemic issues with quality and completeness of study-specific TMFs, recommend solutions, and support team members in implementing mitigation strategies
• Support staff in communications with project teams regarding TMF-related issues and noncompliance with established standards
• Work proactively with staff to anticipate challenges to TMF compliance and identify early signals of risk
• Develop and implement compliance improvement plans and follow up on outstanding noncompliance issues
• Support audits and inspections and attend audit/inspection meetings as needed
• Address escalations related to TMF issues and lead the implementation of solutions and mitigation strategies
• Support team members on internal and external study calls when issues or escalations arise
• Contribute to Business Development activities, including proposal responses and participation in Bid Defense meetings related to TMF processes
• Monitor team member study assignments in line with budgets and oversee reporting of potential out-of-scope activities to the Project Manager as needed
• Oversee staff performing responsibilities within Sponsor eTMF Systems, providing insightful solutions to challenges they face
• Engage with cross-functional stakeholders and Sponsors to proactively resolve emerging issues with TMF completeness or quality

• Conduct weekly or biweekly one-on-one meetings with direct reports to discuss workload, priorities, performance, and professional development
• Ensure effective prioritization of work and the team's consistent ability to meet expected timelines with high-quality deliverables
• Complete annual and semi-annual performance reviews, providing clear, direct, and constructive feedback to promote performance excellence
• Identify staff development and training needs to maintain a high level of team performance
• Train team members in the performance of their responsibilities and in the adoption of new and updated processes and procedures
• Review applications, conduct interviews, and make hiring decisions for new team members
• Ensure the team remains fully staffed and capable of supporting all clinical document management requirements
• Execute financial oversight, ensuring team members have assigned studies or tasks for appropriate allocation to billable work and full utilization

• Support process improvement initiatives and process adoption across Clinical Solutions
• Collaborate on drafting SOPs, Forms, and Work Instructions as assigned by leadership
• Communicate observed trends and suggest process improvements and targeted training opportunities for the Records Management team
• Identify gaps in knowledge, process, or understanding among external project team members regarding TMF management expectations, and recommend retraining, communication strategies, or other forms of engagement
• Provide subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practices

• Bachelor's degree or its international equivalent
• A minimum of 8 years of related experience