Clinical Trial Manager I/II
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Job Description
Clinical Trial Manager overseeing Phase 1 clinical research studies for Syneos Health’s life sciences services organization. Managing sites, monitoring, compliance, risks, budgets, and study-team delivery.
Responsibilities:
- Develop, coordinate, and implement Phase 1 clinical research studies at organizational facilities
- Collaborate with principal investigators and liaise among research subjects, client teams, investigators, and clinic operations teams
- Plan logistics and resource usage
- Track study progress against milestones, client deliverables, budgets, and applicable regulations
- 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 recruitment and investigator payments
- Identify clinical data and process risks and develop risk mitigations
- Review study scope, budget, protocol content, contractual obligations, and project parameters
- Escalate risks affecting timelines, quality, budget, or contracted scope to the project manager
- Participate in and present at key meetings, including Kick Off Meetings
- Serve as an escalation point for investigator site communications and accompany CRA team members to sites 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 the Clinical Monitoring Plan
- Ensure CTMS, dashboards, and other systems are configured and available, including UAT and access/audit trail reviews
- Coordinate initial and ongoing study-team training
- Oversee CRA and Central Monitor resourcing, site assignments, conduct, compliance, and delivery risks
- Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards
- Review site and central monitoring documentation and ensure revisions, approvals, specifications, and deadlines are met
- Provide clinical deliverable and risk status updates to clients, project management, and leadership
- Support inspection readiness, corrective action plans, data cuts, and database lock deadlines
- Oversee assigned CRAs and Central Monitors and provide performance feedback to line managers
Requirements:
- 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 potential threats
- Critical thinking to determine causes and appropriate solutions when identifying issues
- Moderate travel may be required, approximately 20%
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive company culture
- Reasonable accommodations for applicants and employees with disabilities, when appropriate
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