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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in executing centralized monitoring strategies and risk-based monitoring plans while ensuring compliance with GCP and regulatory requirements. Proficient in analyzing clinical trial data to identify trends and risks, and effectively communicating findings to stakeholders.
Highest-signal resume keywords
Centralized MonitoringRisk-Based Monitoring (RBM)Clinical Trial Data AnalysisGCP ComplianceStakeholder 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
Clinical ResearchMonitoring ExperienceData AnalysisRisk ManagementProject Management
Soft Skills
Analytical SkillsCritical ThinkingProblem-SolvingCommunication SkillsCross-Functional Collaboration
Tools & Technologies
Clinical Data SystemsAnalytics PlatformsDigital Tools
Industry Keywords
Life SciencesPharmaceutical IndustryCRO EnvironmentICH-GCPIntegrated Quality Risk Management Plan (IQRMP)
About the role
Key responsibilities & impact- Execute centralized monitoring strategies to support clinical trial oversight
- Perform ongoing review and analysis of clinical trial data to identify trends, risks, and signals
- Collaborate with Data Analysts to review technology outputs and investigate identified risks
- Provide input into data requirements and monitoring strategies
- Ensure adherence to RBM plans, SOPs, and industry best practices
- Conduct data surveillance through Central Monitoring platforms
- Identify potential site and study-level risks in alignment with the Integrated Quality Risk Management Plan (IQRMP)
- Support implementation and refinement of risk-based monitoring plans
- Provide risk-based recommendations to improve trial quality and efficiency
- Contribute to root cause analyses and corrective action discussions
- Generate and communicate Central Monitoring findings and insights
- Support Data Quality Teams in assessing the significance and root causes of findings
- Document monitoring activities, findings, and risk escalations
- Ensure timely follow-up and resolution of identified issues
- Partner with Risk Surveillance Leads, Study Leaders, Data Managers, Clinical Scientists, and other stakeholders
- Participate as an active Clinical Trial Team member
- Serve as the primary point of contact for Central Monitoring activities within assigned studies
- Contribute to the development and maintenance of Trial Monitoring Plans
- Support advancement of centralized monitoring methodologies and tools
- Ensure compliance with GCP, regulatory requirements, and Novartis standards
- Contribute to knowledge sharing, training, and best practice development across the Central Monitoring organization
Requirements
What you’ll need- University degree in Life Sciences, Business, Operations, or a related discipline
- Minimum 5 years of experience in clinical research within the pharmaceutical industry or CRO environment
- Minimum 3 years of monitoring experience (central or site monitoring)
- Strong understanding of RBQM, centralized monitoring, KRIs, QTLs, and clinical trial risk management
- Working knowledge of ICH-GCP and international drug development standards
- Strong analytical, critical thinking, and problem-solving skills
- Experience interpreting complex clinical and operational data
- Excellent communication, stakeholder management, and cross-functional collaboration skills
- Experience working within a global matrix organization
- Proficiency with clinical data systems, analytics platforms, and digital tools
- Strong project management and organizational skills
