Precision for Medicine

Precision for Medicine

Manager of Clinical Systems — Records Management (LATAM) About the Role As part of an exciting expansion across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, we are looking for an experienced and driven Manager of Records Management to join our growing LATAM team. This is a pivotal leadership role responsible for building and overseeing a high-performing team of Documents Specialists, Quality Review Specialists, and TMF Leads who ensure the quality and compliance of study-specific Trial Master Files (TMF) across a dynamic portfolio of clinical programs. In this role, you will provide hands-on leadership and strategic oversight to ensure that essential clinical study documents are filed in accordance with Good Clinical Practice (GCP), relevant regulatory requirements, and established Standard Operating Procedures (SOPs). You will also partner closely with cross-functional leadership to drive continuous process improvement and operational efficiency across the Records Management function and broader Clinical Solutions team. This is a remote-eligible position offering the opportunity to make a meaningful impact on clinical trial operations at a regional scale. Responsibilities TMF Oversight & Quality (60%) Oversee staff performing TMF-related activities, including document quality review and processing, TMF quality review, and study-level engagement to ensure filing of essential clinical study documents Review the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements Assist in addressing cross-functional questions related to TMF management and alignment with study-specific documentation Ensure proper execution of role-specific activities and oversee the quality of TMF support provided by Documents Specialists, Quality Review Specialists, and/or TMF Leads Complete periodic and random quality and completeness checks of work performed by team members Review TMF metrics via system reports and dashboards; identify process and staff performance challenges and take corrective action as needed Ensure all required TMF-related documentation is filed accurately in the eTMF system 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 related to issues and noncompliance with TMF-related standards Proactively anticipate challenges to TMF compliance and identify early risk signals; develop and implement plans to increase compliance and follow up on non-compliance Support audits and inspections, attending audit/inspection meetings as required 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 assignments on studies in alignment with budgets; oversee reporting of potential out-of-scope activities to Project Management as needed Oversee staff performing responsibilities in Sponsor eTMF systems and deliver insightful solutions for challenges faced by team members Engage with cross-functional stakeholders and Sponsors to proactively eliminate emerging issues with TMF completeness or quality Staff Management (30%) Conduct weekly or biweekly one-on-one meetings with team members to discuss workload, performance, responsibilities, and professional development Ensure effective prioritization of work and team members' ability to meet expected timelines while delivering quality outcomes Perform annual and semi-annual performance reviews, providing clear and constructive feedback to promote performance excellence Identify staff development and training needs to ensure consistently high-level performance across the team Train staff in the execution of their responsibilities and in the adoption of ongoing and new processes and procedures Review applications, interview candidates, and make informed hiring decisions for new team members Ensure the team is fully staffed and capable of supporting all clinical documents management requirements within the TMF Execute financial oversight and ensure team members have assigned studies or tasks to support appropriate allocation to billable work and full utilization Process Improvement (10%) Support process improvement initiatives and adoption of best practices across Clinical Solutions Collaborate in drafting SOPs, Forms, and Work Instructions as assigned by leadership Communicate emerging trends and recommend process improvements and targeted training for the Records Management team Identify gaps in knowledge, processes, or expectations among external project team members and recommend re-training, communication, and engagement strategies Provide subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practices Requirements Education & Experience Bachelor's degree or international equivalent