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Clinical Trial Manager – Neurology, Psychiatry
Syneos Health. Provide site management oversight, clinical monitoring, and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including site management oversight, risk-based monitoring, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in coordinating clinical activities, managing budgets, and leading teams to achieve project milestones.
Highest-signal resume keywords
Site Management OversightRisk-Based MonitoringGood Clinical Practice/ICH GuidelinesClinical Trial ManagementBudget 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 MonitoringData IntegrityProtocol ComplianceRisk MitigationClinical Study Tools DevelopmentCTMS ConfigurationCRF CompletionPerformance FeedbackInspection ReadinessProblem-Solving Techniques
Soft Skills
Conflict ResolutionCritical ThinkingTeam LeadershipCommunicationCollaboration
Tools & Technologies
CTMSEDCEDiaryEPROsTMFIVRS/IWRSDashboards
Industry Keywords
Clinical Trial ManagementPatient SafetyRegulatory ComplianceProtocol ExecutionInternational Environment
About the role
Key responsibilities & impact- Provide site management oversight, clinical monitoring, and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity
- Oversee site interactions from post-activation through site closeout, including patient recruitment and investigator payments when applicable
- Identify critical data, process, protocol execution risks, and risk mitigations related to the RACT
- Review study scope of work, budget, and protocol content; ensure clinical project team awareness of contractual obligations and parameters
- Identify and escalate risks to clinical trial management deliverables, including timeline, quality, budget, and out-of-scope activities
- Propose and implement risk mitigations and participate in key meetings such as Kick Off Meetings
- Serve as an escalation point for investigator site staff communications and interact with principal investigators and site staff by phone or in person
- Accompany CRA team members to sites for observation or conflict resolution when required
- Collaborate with Study Start Up, Patient Recruitment, Data Management, and other functional leaders to meet study milestones
- Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
- Ensure CTMS, dashboards, and other systems are configured and available, including overseeing UAT as needed
- Coordinate initial and ongoing study-team training on protocol requirements, CRF completion, dashboards, SOPs, clinical plans, data plans, and timelines
- Oversee CRA and Central Monitor resourcing, site assignments, team conduct, quality, and delivery visibility
- Review project oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards
- Ensure monitoring strategy, CMP/SMP, and risk-plan compliance among assigned clinical team members
- Review site and central monitoring documentation for quality, completeness, and risks to protocol/GCP compliance, trial conduct, patient safety, and data integrity
- Interact with clients, project management, leadership, and functional departments; provide status updates and solutions for protocol execution and site-management obstacles
- Support inspection readiness for clinical trial management scope
- Assess process, training, and CMP compliance; develop and support corrective action plans
- Support activities needed to achieve data cut and database lock deadlines
- Provide performance feedback to line managers
- Coordinate clinical activities for CTM teams across larger, more complex trials or portfolios when assigned
- Coach and mentor CTMs regarding clinical delivery, project risks, and action implementation when assigned
Requirements
What you’ll need- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
- Demonstrated ability to lead and align teams in the achievement of project milestones
- Demonstrated capability of working in an international environment
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills
- Strong conflict resolution skills
- Ability to apply problem-solving techniques to resolve complex issues and use a risk management approach to identify and mitigate potential threats to successful clinical research project conduct
- Critical-thinking ability to determine causes and appropriate solutions when identifying issues
- Moderate travel may be required, approximately 20%
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate