Manager, Records Management (LATAM)

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we’re looking for a Manager of Clinical Systems to build our Records Management team in LATAM!

Our Manager of Records Management oversees and manages a team of Documents Specialists, Quality Review Specialists, and/or TMF Leads who are responsible for the quality of study specific Trial Master Files (TMF). You'll oversee activities including document review and processing; TMF quality reviews; and study-level engagement to ensure filing of essential clinical study documents in accordance with Good Clinical Practice, other relevant regulations, and Precision Standard Operating Procedures (SOPs).

As the Manager of Records Management, you'll be accountable for providing team members with support, training, performance management, and back-up across the portfolio of clinical programs. Further, the Manager collaborates with leadership to ensure continuous process improvement and efficiency across the Records Management team and Clinical Solutions.

Responsibilities:

TMF Oversight & Quality (60%)

• Oversee staff performing TMF-related activities which may include document quality review and processing, TMF quality review, and/or study-level engagement to ensure filing of essential clinical study documents • Perform review of the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements • Assist with addressing any 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 and identifies process and staff performance challenges • Ensure any TMF-related documentation is filed in the eTMF when required • Identify systemic issues with quality and completeness of study-specific TMFs, recommend solutions and support team members in implementation of mitigation strategies • Support staff in communications with project teams related to issues and noncompliance with TMF-related standards • Work with staff to proactively anticipate challenges to TMF compliance and identify early signals of risk • Develop and implement plans to increase compliance and follows-up on non-compliance • Support audits and inspections and attend audit/inspection meetings when needed • Address escalations related to TMF issues and lead implementation of solutions and mitigation strategies • Support team members on internal and external study calls if issues and escalations emerge • Support Business Development activities, such as Proposal responses or participation at Bid Defense meetings related to TMF processes • Monitor team member assignments on studies in line with budgets and oversee the reporting of potential out of scope activities to PM, as needed • Oversee staff performing job responsibilities in Sponsor eTMF Systems and actively listen to deliver insightful solutions for challenges faced by team members • Engage with cross-functional stakeholders and Sponsors to eliminate emerging issues with completeness or quality <p