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Clinical Trial Manager II – Sponsor Dedicated
Syneos Health. Provide site management oversight, clinical monitoring and central monitoring deliverables focused 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 site management and monitoring, ensuring compliance with Good Clinical Practice and regulatory requirements while effectively leading teams to achieve project milestones. Proficient in risk management and problem-solving techniques to address complex issues in clinical trial management.
Highest-signal resume keywords
Clinical Site ManagementRisk-Based MonitoringGood Clinical PracticeBudget ManagementProblem-Solving Techniques
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 Trial ManagementStudy Scope ReviewTraining CoordinationCorrective Action PlansSite Interaction OversightPerformance Feedback
Soft Skills
Communication SkillsInterpersonal SkillsConflict ResolutionCritical ThinkingTeam Leadership
Tools & Technologies
CTMSEDCEDiaryEPROsTMFIVRS/IWRSDashboardsClinical Monitoring PlanStudy ToolsAudit Trail Reviews
Industry Keywords
Clinical TrialsRegulatory ComplianceInternational EnvironmentProject MilestonesPatient Recruitment
About the role
Key responsibilities & impact- Provide site management oversight, clinical monitoring and central monitoring deliverables focused 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
- Identify critical data, process and protocol execution risks and develop risk mitigations
- Review study scope of work, budget and protocol content and ensure clinical project teams understand contractual obligations and parameters
- Identify and escalate risks to timelines, quality, budget and contracted scope
- Participate in and present at key meetings, including 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
- 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 set up, available and properly maintained, including UAT and access/audit trail reviews
- Coordinate initial and ongoing study-team training on protocols, CRF completion, dashboards, SOPs, plans, guidelines, data plans and timelines
- Oversee CRA and Central Monitor resourcing, site assignments and study-team conduct
- Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables
- Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards
- Oversee compliance with monitoring strategies, CMP/SMP and risk plans
- Review site and central monitoring documentation and ensure revisions, approvals and deadlines are completed
- Interact with clients, project management, leadership and functional departments; provide status updates and solutions
- Support inspection readiness for clinical trial management scope
- Oversee CRAs and Central Monitors, assess compliance and identify emerging risks
- Develop and support corrective action plans and activities to achieve data cut and lock deadlines
- Provide staff performance feedback to line managers
- May be assigned to larger, more complex trials
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
- Good communication, presentation and interpersonal skills among project team and with sites
- Strong conflict resolution skills
- Ability to apply problem-solving techniques to resolve complex issues and apply a risk-management approach
- Critical thinking to determine causes and appropriate solutions
- 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