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Fortrea

Manager, Centralized Monitoring

Fortrea

. Review monitoring trip reports for quality, compliance, and best-practice implementation .

Posted 10/12/2026full-timeBuenos Aires • ArgentinaSeniorLeadWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in centralized monitoring, risk management, and compliance with ICH-GCP and Fortrea SOPs. Proficient in training and mentoring teams while managing multiple clinical research studies and ensuring quality oversight.

Highest-signal resume keywords
Centralized MonitoringRisk ManagementICH-GCP ComplianceClinical Research ExperienceProject Management

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Trip Report ReviewETMF ReconciliationStudy AnalyticsRisk Assessment DevelopmentSDV StrategiesData-Driven RecommendationsProcess MappingLEAN/Six Sigma InitiativesDashboard DevelopmentUser Acceptance Testing
Soft Skills
Detail-Focused Analytical SkillsProblem-Solving SkillsInterpersonal SkillsInfluencing SkillsCommunication Skills
Tools & Technologies
MS Office SuiteEDCCTMSCentral Monitoring Tools
Certifications & Qualifications
Nursing CertificationMedical Technology CertificationLaboratory Technology Certification
Industry Keywords
Clinical Development ProgramsFortrea SOPsRegulatory RequirementsQuality OversightInspection Readiness

About the role

Key responsibilities & impact
  • Review monitoring trip reports for quality, compliance, and best-practice implementation
  • Identify and communicate 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, and study teams on issue escalation and resolution
  • Train and mentor CRAs, IHCRAs, and new CMLs on trip reports, monitoring activities, ICH-GCP, SOPs, and work instructions
  • 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
  • Contribute to XRR dashboard development, including dashboard and visualization design using sources such as EDC and CTMS
  • Configure central monitoring tools and study-specific parameters and perform user acceptance testing
  • Review and approve changes to monitoring levels and provide data-driven recommendations
  • Manage a portfolio of studies and serve as a key customer point of contact
  • Lead and support central monitoring teams and oversee risk tracking, analysis, reporting, and monitoring status
  • Support PMO activities, proposals, bid defense materials, costing reviews, sponsor presentations, and quality/risk reports
  • Provide direct people management for 8–20 staff, including performance management, coaching, resource planning, recruitment, and issue resolution
  • Monitor performance indicators, workload, billable hours, utilization, productivity, budgets, and resource needs
  • Ensure compliance with Fortrea SOPs, ICH-GCP, client requirements, work instructions, and regulatory requirements
  • Support inspection readiness, corrective actions, training completion, onboarding, and quality oversight
  • Contribute to SOP development, process mapping, LEAN/Six Sigma initiatives, and continuous improvement
  • Manage assigned projects under the direction of a Project Manager or Director
  • 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 another 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, inclusive of 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)
  • Fluent in English and the local language
  • Ability to plan, prioritize, organize, and communicate effectively
  • Detail-focused analytical and problem-solving skills
  • Strong interpersonal skills with ability to influence, lead, and work well with others
  • Ability to participate in process improvement initiatives
  • Demonstrated project and risk management skills
  • Knowledge of Fortrea and its organizational structure (preferred)
  • Knowledge of Fortrea standard operating procedures (preferred)
  • Ability to travel occasionally, including domestic and international travel
  • Regular and consistent attendance
  • Varied hours may be required

Benefits

Comp & perks
  • Hybrid work arrangement
  • Occasional domestic and international travel
  • Training and development opportunities
  • Coaching and mentoring opportunities
  • Participation in process improvement initiatives
  • EEO and accommodations support