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Clinical Trial Manager II
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 monitoring and site management, 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 maintain data integrity and patient safety throughout clinical trials.
Highest-signal resume keywords
Clinical MonitoringSite ManagementRisk-Based MonitoringGood Clinical PracticeBudget 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 Trial ManagementData IntegrityProtocol ComplianceRisk ManagementCritical Thinking
Soft Skills
Communication SkillsConflict ResolutionInterpersonal SkillsPresentation SkillsTeam Leadership
Tools & Technologies
CTMSEDCEDiaryEPROTMFIVRS/IWRS
Industry Keywords
Good Clinical PracticeICH GuidelinesClinical Monitoring PlanPatient SafetyRegulatory Compliance
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 activation through closeout, including recruitment and investigator payments
- Identify critical data, process and protocol execution risks and develop mitigations
- Review study scope, budget and protocol content; communicate contractual obligations to CRAs and Central Monitors
- 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 and interact with principal investigators and site staff by phone or in person
- Coordinate with Study Start Up, Patient Recruitment and Data Management to achieve study milestones
- Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
- Ensure CTMS, dashboards and other systems are configured, available and subject to required UAT and audit-trail reviews
- Coordinate study-team training on protocols, CRF completion, dashboards, SOPs, plans and timelines
- Oversee CRA and Central Monitor resourcing, site assignments, conduct, compliance and delivery risks
- Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables
- Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central monitoring dashboards to oversee site and patient activities
- Oversee compliance with monitoring strategies, CMP/SMP and risk plans
- Review site and central monitoring documentation for quality, compliance, patient safety, trial conduct and data integrity
- Interact with clients, project management, leadership and functional departments; provide status updates and solutions
- Support inspection readiness for clinical trial management
- Oversee CRAs and Central Monitors, assess compliance and emerging risks, and support corrective action plans
- Support activities to achieve data-cut and database-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 use a risk-management approach to identify and mitigate threats to successful clinical research projects
- 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 and total rewards program
- Total Self culture
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time