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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 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
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 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
