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Global Clinical Trial Manager II
Syneos Health. Manage all aspects of the development, coordination, and implementation of Phase 1 through Phase 4 clinical research studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical research studies from Phase 1 to Phase 4, including site management, risk mitigation, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in coordinating cross-functional teams and ensuring project milestones are met within budgetary constraints.
Highest-signal resume keywords
Clinical Trial ManagementSite ManagementRisk-Based MonitoringBudget ManagementGood Clinical Practice/ICH Guidelines
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 ResearchProject ManagementRisk MitigationClinical MonitoringData Management
Soft Skills
Conflict ResolutionCritical ThinkingProblem-SolvingTeam Leadership
Tools & Technologies
CTMSEDCEDiaryEPROTMFIVRS/IWRS
Certifications & Qualifications
Bachelor’s DegreeRN
Industry Keywords
Clinical TrialsRegulatory ComplianceInternational EnvironmentStudy LogisticsPatient Recruitment
About the role
Key responsibilities & impact- Manage all aspects of the development, coordination, and implementation of Phase 1 through Phase 4 clinical research studies
- Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams
- Plan study logistics and resource usage
- Track study progress against milestones, client deliverables, budgets, and applicable regulations
- Oversee site interactions from post-activation through site closeout, including patient recruitment and investigator payments
- Identify clinical trial risks and develop or implement risk mitigations
- Review study scope, budgets, protocols, and contractual obligations
- Participate in and present at key meetings, including Kick Off Meetings
- Serve as an escalation point for investigator site communications and support site visits when needed
- Coordinate delivery handoffs with Study Start Up, Patient Recruitment, Data Management, and other functional leaders
- Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans
- Ensure CTMS, dashboards, and other systems are configured and available, including overseeing UAT as needed
- Coordinate initial and ongoing study-team training
- Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks
- Ensure quality and visibility of clinical monitoring, central monitoring, and site management deliverables
- Review clinical trial systems and dashboards, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards
- Oversee monitoring strategy compliance, documentation quality, corrective action plans, and data cut and lock activities
- Provide status updates and solutions to clients, project management, and leadership
- Support inspection readiness for clinical trial management scope
- Provide performance feedback to line managers
- Coordinate clinical activities for larger or more complex trials and coach or mentor CTMs
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 apply a risk management approach
- Critical thinking 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, for employees or applicants with disabilities