Description
Syneos Health is seeking a Senior Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables. The successful candidate will be responsible for ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.
Responsibilities:
- Provide site management oversight, clinical monitoring, and central monitoring deliverables
- Review study scope of work, budget, and protocol content
- Identify risks to clinical trial management deliverables and escalate to project manager
- Employ strategic thinking and problem-solving skills to propose and implement risk mitigations
- Serve as an escalation point for communications with investigator site staff
- Collaborate with other functional leaders to coordinate delivery handoffs and meet expected study milestones
- Develop and maintain clinical study tools and templates
- Coordinate training to the study team
- Oversee resourcing allocations for CRAs and Central Monitors
- Review project oversight dashboards and other clinical trial systems
- Understand the monitoring strategy required for the study
- Review content and quality of site and central monitoring documentation
- Interact with the client and other functional departments
- Demonstrate understanding of other functions' roles in achieving compliance and delivery
- Oversee CRAs and Central Monitors assigned to the study
- Provide feedback to line managers on staff performance
Qualifications:
- 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
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Strong conflict resolution skills
- Moderate travel may be required, approximately 20%