Description
Syneos Health is seeking a Clinical Trial Manager to join their Clinical Solutions team. The successful candidate will be responsible for managing clinical trials from Phase 1 to Phase 4, ensuring compliance with regulations, and delivering high-quality results.
Responsibilities:
- Manage clinical trials from initiation to close-out
- Ensure compliance with regulations, GCP, and protocol
- Coordinate with cross-functional teams, including investigators, research subjects, and client teams
- Develop and implement risk mitigation strategies
- Oversee site management, clinical monitoring, and central monitoring deliverables
- Review and provide feedback on study plans, budgets, and protocols
- Identify and escalate risks to clinical trial management deliverables
- Collaborate with other functional leaders to coordinate delivery handoffs and meet study milestones
- Develop and maintain clinical study tools and templates
- Provide training to study teams on protocol specifics, CRF completion, and Sponsor SOPs
- Oversee resourcing allocations for CRAs and Central Monitors
- Ensure quality of clinical monitoring, central monitoring, and site management deliverables
- Review project oversight dashboards and clinical trial systems to ensure data accuracy and timeliness
Requirements:
- Bachelor's degree or RN in a related field or equivalent experience
- Demonstrated ability to lead and align teams in achieving project milestones
- Experience working in an international environment
- Expertise in site management and monitoring (clinical or central)
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Strong communication, presentation, and interpersonal skills
- Ability to apply problem-solving techniques to resolve complex issues
- Moderate travel required (approximately 20%)