Manager, Records Management – LATAM

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Supervise personnel engaged in TMF-related tasks, which may involve document quality assessment and processing, TMF quality evaluation, and/or study-level involvement to ensure the filing of crucial clinical study documents.

• Conduct a review of the study TMF Plan and TMF Document Index to verify that staff activities align with study-specific requirements.

• Aid in addressing any cross-functional inquiries related to TMF management and the alignment of study-specific documentation.

• Ensure the effective execution of role-specific responsibilities and oversee the quality of TMF support provided by Document Specialists, Quality Review Specialists, and/or TMF Leads.

• Carry out periodic and random quality and completeness checks of team members' work.

• Assess TMF metrics via system reports and dashboards to identify challenges in processes and staff performance.

• Confirm that any TMF-related documentation is filed in the eTMF as necessary.

• Recognize systemic issues concerning the quality and completeness of study-specific TMFs, propose solutions, and support team members in executing mitigation strategies.

• Assist staff in communicating with project teams regarding issues and noncompliance with TMF-related standards.

• Collaborate with staff to proactively foresee challenges to TMF compliance and identify early indicators of risk.

• Create and implement strategies to enhance compliance and follow up on instances of non-compliance.

• Provide support for audits and inspections and participate in audit/inspection meetings as needed.

• Address escalations pertaining to TMF issues and lead the execution of solutions and mitigation strategies.

• Assist team members during internal and external study calls if issues and escalations arise.

• Support Business Development efforts, including proposal responses or participation in Bid Defense meetings related to TMF processes.

• Oversee team member assignments on studies in accordance with budgets and manage the reporting of potential out-of-scope activities to PM when necessary.

• Supervise staff fulfilling job responsibilities in Sponsor eTMF Systems and actively listen to provide insightful solutions for challenges faced by team members.

• Collaborate with cross-functional stakeholders and Sponsors to resolve emerging issues related to completeness or quality.

⛳️ Requirements

• Bachelor’s degree (or its international equivalent).

• At least 8 years of relevant experience, including a minimum of 2 years in a leadership role, or an equivalent combination of education, professional training, and experience that equips the individual with the necessary knowledge, skills, and abilities to perform the job.

• Professional working proficiency in English.

• Familiarity with eTMF systems and vendors.

• Proven record of implementing processes and standardization for tracking and reporting clinical trials.

• Solid understanding of FDA & ICH/GCP regulations and guidelines.

• Established experience and proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint).

• Exceptional organizational skills, time management, and the ability to coordinate workload and meet established deadlines.

• Outstanding verbal and written communication skills.

• Strong problem-solving abilities.

• Demonstrates effective interpersonal skills.

• Exhibits a high level of self-motivation, attention to detail, and the ability to work and plan independently as well as within a team environment.

• Communicates efficiently and professionally in both verbal and written formats.

• Displays professionalism, as evidenced by punctuality, commitment to delivering on obligations, strong interpersonal skills, and maintaining positive interactions with internal and external stakeholders.

• Upholds values and a work ethic consistent with Precision Values and Company Principles.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.