Manager, Records Management – LATAM
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Manager of Clinical Systems overseeing Records Management team across LATAM for Precision for Medicine. Responsible for quality assurance and support duties with a focus on compliance.
Responsibilities:
- 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
Requirements:
- 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
- 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
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
- Demonstrates 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
Similar Jobs
Manager, AP/AR
AP/AR Manager overseeing finance operations at General Dynamics Ordnance and Tactical Systems. Preparing and analyzing accounts payable/receivable transactions with team supervision.
Care Team Manager
Manager leading and developing a team of Health Pros at Alight Solutions. Responsible for operational processes and meeting quality standards within a flexible workspace.
IT Portfolio Manager
TI Portfolio Manager managing strategic portfolio of projects in a manufacturing setup. Ensuring alignment between business objectives and IT deliverables while improving operational efficiency.
Market Development Manager
Market Development Manager at Secura Bio, capturing KOL insights to inform oncology brand strategy. Collaborating with cross-functional teams to identify marketing opportunities.
Senior Manager, Pretzels & Bold Snacking Brand
Senior Manager leading brand equity and activation marketing for Dot’s Pretzels within The Hershey Company. Driving brand relevance and sales growth with a strategic, consumer-first approach.
Distributor – Market Development Manager
Distributor & Market Development Manager at Insulet driving sustainable growth through distributor partnerships. Collaborating across cross-functional teams to enhance commercial strategies and patient outcomes.
Operational Business Management, Manager
Operational Business Management Manager at Amgen supporting budget forecasting and resource capacity planning activities. Collaborating with stakeholders to ensure operational efficiency and financial discipline in global operations.
Associate Site Activation Manager
Associate Global Site Activation Manager overseeing site activation for clinical trials. Leading country operations teams to ensure timely client commitments and execution of global activation strategies.
Democracy Defense Manager
Democracy Defense Manager with All Voting is Local, focusing on defending election integrity in Arizona. Leading coalitions, managing campaigns, and addressing threats to voting rights.
Interim Senior Learning and Evaluation Manager – Short-Term Consultancy
Interim Senior Learning and Evaluation Manager supporting Global Fund for Children with outcomes management and evaluation. Engaging with community-based organizations to enhance the lives of children and youth globally.
Family Offices Services Manager
Family Office Services Manager leading investment services delivery for ultra-high-net-worth client families. Managing capital and constructing portfolios while coordinating with wealth management advisors.
Senior UA Manager, Core, TikTok
Senior UA Manager responsible for TikTok UA across dating portfolio. Join social discovery group improving connection on a global scale.
Senior UA Manager, Core
Senior UA Manager overseeing Facebook user acquisition for dating portfolio. Focus on campaign management, scaling, and automation improvements across web funnels with a B2C approach.
Senior Contract Manager
Senior Contracts Manager responsible for U.S. Government contracts at GE Aerospace. Ensuring compliance and effective contract management across all phases of contract lifecycle.
Senior Manager, Deployment
Senior Manager responsible for leading telecommunications deployment initiatives and cross-functional teams. Ensuring project delivery aligns with carrier standards and business goals.
Projektmanager, m/w/d
Project Manager leading healthcare software projects for Dedalus, ensuring client-focused delivery and team coaching. Requires strong analytical skills and project management experience in the healthcare sector.
General Ledger Manager
General Ledger Manager at Milliman overseeing GL team management and financial reporting responsibilities. Collaborating with finance teams for journal entry preparation and process enhancements.
Manager, Records Management – LATAM
Manager of Clinical Systems responsible for building Records Management team in LATAM. Overseeing TMF processes and ensuring compliance in clinical trials documentation.
IT CSV Manager
IT CSV Manager overseeing the strategy and compliance of validation for GxP-regulated IT systems in a remote setup. Contributing to a mission-driven organization focused on healthcare access and data insights.
Manager, Case Management – RN License Required
Manager overseeing high-performing case management team for Medicare Advantage SNP at Alignment Health. Driving compliance and quality care outcomes for members with complex healthcare needs.