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Manager, Records Management (LATAM)

Remote, Brazil; Remote, Mexico

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-ups 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

Staff Management (30%)

• Perform weekly or biweekly 1:1 meetings with team members to discuss workload, responsibilities, performance, and related topics
• Ensure effective prioritization of work, and team members' ability to meet expected timelines with quality deliverables
• Perform 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 performance
• Train staff in the performance of their responsibilities, and in the performance of ongoing and new processes and procedures
• Review and interviews candidates and make hiring decisions for new team members
• Ensure the team is fully staffed and able to support the requirements of clinical documents management in the TMF
• Execute 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 Solutions
• Collaborate on drafting SOPs, Forms, and Work Instructions as assigned by leadership
• Communicate trends and suggest process improvements and potential training for Records Management Team
• Identify 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 engagement
• Provide subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practices

Minimum Education & Experience:

• Bachelor's degree (or its international equivalent)
• A minimum of 8 years of related experience, including a minimum of 2 years in a leadership capacity Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
• Professional working proficiency in English

Knowledge, Skills, and Competencies:

• Experience with eTMF systems and vendors
• Track record of implementing process and standardization for tracking and reporting clinical trials
• Working knowledge of FDA & ICH/GCP regulations and guidelines
• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Excellent verbal and written communication skills
• Excellent problem-solving skills
• Demonstrates solid interpersonal skills
• Demonstrates, or able to train and retain, a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles