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 documentsPerform review of the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirementsAssist with addressing any cross-functional questions related to TMF management and alignment with study-specific documentationEnsure proper execution of role-specific activities and oversee the quality of TMF support provided by Documents Specialists, Quality Review Specialists and/or TMF LeadsComplete periodic and random quality and completeness checks of work performed by team membersReview 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 requiredIdentify systemic issues with quality and completeness of study-specific TMFs, recommend solutions and support team members in implementation of mitigation strategiesSupport staff in communications with project teams related to issues and noncompliance with TMF-related standardsWork 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-complianceSupport audits and inspections and attend audit/inspection meetings when neededAddress escalations related to TMF issues and lead implementation of solutions and mitigation strategiesSupport team members on internal and external study calls if issues and escalations emergeSupport Business Development activities, such as Proposal responses or participation at Bid Defense meetings related to TMF processesMonitor team member assignments on studies in line with budgets and oversee the reporting of potential out of scope activities to PM, as neededOversee staff performing job responsibilities in Sponsor eTMF Systems and actively listen to deliver insightful solutions for challenges faced by team membersEngage with cross-functional stakeholders and Sponsors to eliminate emerging issues with completeness or qualityStaff Management (30%) Perform weekly or biweekly 1:1 meetings with team members to discuss workload, responsibilities, performance, and related topicsEnsure effective prioritization of work, and team members’ ability to meet expected timelines with quality deliverablesPerform annual and semi-annual (if required) performance reviews, providing clear and direct feedback to promote performance excellence. Identify staff development and training needs to ensure high level performanceTrain staff in the performance of their responsibilities, and in the performance of ongoing and new processes and proceduresReview and interviews candidates and make hiring decisions for new team membersEnsure the team is fully staffed and able to support the requirements of clinical documents management in the TMFExecute financial oversight and ensure team members have assigned studies or tasks for appropriate allocation to billable work and full utilization Process Improvement (10%) Support process improvement initiatives and process adoption across Clinical SolutionsCollaborate on drafting SOPs, Forms, and Work Instructions as assigned by leadershipCommunicate trends and suggest process improvements and potential training for Records Management TeamIdentify gaps in knowledge, processes or learning among external project team members in expectations for TMF management and recommend re-training, communication, and other forms of engagementProvide subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practicesMinimum Education & Experience: Bachelor’s degree (or its international equivalent) A minimum of 8 years of related experience, including a minimum of 2 year