Manager, Centralized Monitoring

Fortrea

. Review trip reports for quality, compliance, best practices, risks, trends, protocol deviations, safety concerns, and outstanding issues .

Posted 10/12/2026full-timeMexico City • MexicoSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Research, including Trip Report Review, Centralized Monitoring, and Risk Management. Proficient in ICH-GCP compliance, project management, and team leadership, with a focus on continuous improvement and effective communication.

Highest-signal resume keywords

Clinical Research ExperienceCentralized MonitoringRisk ManagementICH-GCP KnowledgeProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Trip Report ReviewCentral Monitoring PlansETMF ReconciliationStudy Risk AssessmentsData InterpretationSDV StrategiesProcess MappingLEAN/Six SigmaAnalytical SkillsIssue Management

Soft Skills

Interpersonal SkillsProblem-Solving SkillsCommunication SkillsLeadership SkillsDetail-Focused

Tools & Technologies

MS Office SuiteEDCCTMSCentral Monitoring ToolsDashboard Development

Certifications & Qualifications

Nursing CertificationMedical Technology CertificationLaboratory Technology Certification

Industry Keywords

Clinical Development ProgramsRegulatory RequirementsSOP DevelopmentQuality OversightInspection Readiness

About the role

Key responsibilities & impact

Review trip reports for quality, compliance, best practices, risks, trends, protocol deviations, safety concerns, and outstanding issues
Execute and oversee site-, regional-, and study-level centralized monitoring activities across multiple studies
Collaborate with CRAs, CTLs, Project Managers, Global CTLs, study teams, and clinical operations teams
Track issues through resolution and escalate risks, changes, and concerns appropriately
Train and mentor CRAs, IHCRAs, new CMLs, and internal and external project teams
Develop and maintain trip report templates, guidelines, Central Monitoring Plans, Configuration Plans, and controlled documents
Perform eTMF reconciliation, protocol deviation review and trending, issue management, and study analytics
Develop study risk assessments, risk factors, trigger thresholds, SDV strategies, mitigation plans, and RACT contributions
Manage a portfolio of studies and serve as a key customer point of contact
Track, interpret, and apply data to manage risk and recommend monitoring strategy and intervention-level changes
Support Critical Data and Critical Process Definitions
Contribute to study-specific XRR dashboard development and visualizations using sources such as EDC and CTMS
Configure central monitoring tools, risk factors, thresholds, and parameters; perform UAT
Plan, lead, conduct, and follow up on central monitoring activities and dashboard/analytics reviews
Support PMO activities, including Risk Management Registers, Study Risk Impact Reports, and site risk weighting
Contribute to proposals, bid defence materials, costing reviews, and sponsor presentations
Oversee Project Quality and Risk Reports for compliance and client satisfaction
Provide technical leadership and ensure monitoring processes, tools, and risk-based approaches are implemented effectively
Contribute to SOP development, process mapping, LEAN/Six Sigma, and continuous improvement initiatives
Manage assigned projects under a Project Manager or Director and ensure timely communication
Ensure compliance with Fortrea SOPs, ICH-GCP, regulatory requirements, and client procedures
Provide direct people management for 8–20 staff, including supervision, performance management, coaching, hiring, resource planning, and resolving performance issues
Monitor performance indicators, identify training needs, and support development efforts
Provide GCP and quality oversight, inspection readiness, and regulatory inspection support
Monitor workload, billable hours, utilization, productivity, budgets, expenses, and resource planning
Support recruitment, expense management, and financial authority processes
Perform other duties as assigned

Requirements

What you’ll need

University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (e.g., Nursing Certification, Medical or Laboratory Technology)
Post-graduation in Life sciences or any other applicable qualification and experience is recommended
Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements
2 years of experience in the job discipline, including trip report review and/or centralized monitoring/risk-based monitoring experience
10–12 years of clinical research experience in other professional roles
Working knowledge of ICH GCP, including internal regulatory requirements for clinical development programs
Advanced computer skills, including MS Office Suite (Word, Excel, PowerPoint)
Fluency in English and the local language, in speaking, writing, and reading
Ability to plan, prioritize, organize, and communicate effectively
Detail-focused analytical and problem-solving skills
Strong interpersonal skills and ability to influence, lead, and work well with others
Ability to participate in process improvement initiatives
Project and risk management skills
Knowledge of Fortrea and its organizational structure (preferred)
Knowledge of Fortrea standard operating procedures (preferred)
Ability to access and use in-house and off-the-shelf computer software
Ability to travel occasionally, including to site locations and domestically and internationally
Regular and consistent attendance
Ability to work varied hours when required

Benefits

Comp & perks

Hybrid work arrangement
Occasional domestic and international travel
Training and development opportunities
Coaching and mentoring opportunities
Regular and consistent attendance
EEO and accommodations support