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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in centralized monitoring, risk-based monitoring, and compliance with ICH-GCP and regulatory requirements. Proficient in data analysis, trip report review, and leading cross-functional teams to ensure quality and safety in clinical research.
Highest-signal resume keywords
Centralized MonitoringRisk-Based MonitoringICH-GCP ComplianceData AnalysisProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Trip Report ReviewETMF ReconciliationProtocol Deviation ReviewStudy AnalyticsRisk AssessmentData InterpretationMonitoring Strategy DevelopmentSOP DevelopmentLEAN/Six SigmaPerformance Management
Soft Skills
Interpersonal SkillsProblem-Solving SkillsCommunication SkillsOrganizational SkillsLeadership Skills
Tools & Technologies
MS Office SuiteMonitoring ToolsXRR DashboardUAT
Certifications & Qualifications
Nursing CertificationMedical Technology CertificationLaboratory Technology Certification
Industry Keywords
Clinical ResearchFortrea SOPsRegulatory RequirementsRisk ManagementContinuous Improvement
About the role
Key responsibilities & impact- Review monitoring trip reports for quality, compliance, best-practice implementation, 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 study teams, CRAs, CTLs, Project Managers, Global CTLs, and other stakeholders to track, escalate, and resolve issues
- Ensure implementation of risk plans and recommend changes to monitoring strategies and intervention levels
- Lead centralized monitoring activities, dashboard reviews, analytics, data interpretation, and data-driven recommendations
- 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, study analytics, and risk/status reporting
- Support study risk assessments, risk factor definitions, trigger thresholds, SDV strategies, mitigation plans, RACT, Critical Data and Critical Process Definitions
- Contribute to XRR dashboard development and configure monitoring tools, risk factors, thresholds, and parameters; perform UAT
- Review, approve, and escalate monitoring-level changes in compliance with plans and sponsor requirements
- Manage assigned customer study portfolios and serve as a key customer point of contact
- Provide technical leadership and coach internal and external teams on centralized and risk-based monitoring
- Lead and manage 8–20 direct reports, including performance management, coaching, hiring, resource planning, training, and issue resolution
- Support PMO, proposals, bid defense, costing reviews, sponsor presentations, quality and risk reports, financial oversight, and inspection readiness
- Contribute to SOP development, process mapping, LEAN/Six Sigma, and continuous improvement initiatives
- Ensure compliance with Fortrea SOPs, ICH-GCP, regulatory requirements, client requirements, and established corrective-action processes
- Communicate workload, billable hours, utilization, productivity, training needs, and performance indicators
- 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, and PowerPoint
- English and fluent local language proficiency in speaking, writing, and reading
- Demonstrated 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 the overall structure of the organization preferred
- Knowledge of Fortrea standard operating procedures preferred
- 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