Clinical Trial Manager, Home based Romania
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Job Description
Clinical Trial Manager overseeing site management, monitoring, and compliance for Phase 1–4 studies. Supporting Syneos Health’s global drug development and commercialization services.
Responsibilities:
- Develop, coordinate, and implement Phase 1 through Phase 4 clinical research studies
- Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams
- Plan logistics and resource usage
- Track study progress against milestones, deliverables, budgets, and applicable regulations
- Oversee site management, clinical monitoring, and central monitoring deliverables
- Oversee site interactions from activation through closeout, including recruitment and investigator payments
- Identify clinical trial risks and implement mitigations
- Review scope of work, budgets, protocols, and contractual obligations
- Escalate timeline, quality, budget, and out-of-scope risks to the project manager
- Participate in key meetings, including Kick Off Meetings
- Serve as an escalation point for investigator site communications
- Coordinate 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 UAT
- Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, and timelines
- Oversee CRA and Central Monitor resourcing, assignments, conduct, and delivery risks
- Review monitoring documentation and ensure quality, compliance, and timely delivery
- Provide status updates and solutions to clients, project management, and leadership
- Support inspection readiness, corrective action plans, data cuts, and database lock deadlines
- 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 apply a risk management approach
- Critical thinking to determine causes and appropriate solutions
- Approximately 20% travel may be required
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Moderate travel may be required, approximately 20%
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