Description
Syneos Health is seeking a Clinical Trial Manager II to join their Clinical Solutions team. The successful candidate will be responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
Key responsibilities include:
- Overseeing site interactions post-activation through site closeout
- Identifying critical data and processes, protocol execution risks, and risk mitigations
- Reviewing study scope of work, budget, and protocol content
- Using prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables
- Escalating risks to clinical trial management deliverables to the project manager
- Employing strategic thinking and problem-solving skills to propose and implement risk mitigations
- Participating in key meetings such as Kick Off Meetings
- Serving as an escalation point for communications with investigator site staff
- Collaborating with other functional leaders to coordinate delivery handoffs and meet expected study milestones
- Developing and maintaining clinical study tools and templates
- Coordinating initial and ongoing training to the study team
- Overseeing resourcing allocations for CRAs and Central Monitors
- Ensuring quality of clinical monitoring, central monitoring, and site management deliverables
- Reviewing project oversight dashboards and other clinical trial systems
- Understanding the monitoring strategy required for the study
- Reviewing content and quality of site and central monitoring documentation
- Interacting with clients and other functional departments
- Demonstrating understanding of other functions' roles in achieving compliance and delivery
- Overseeing CRAs and Central Monitors assigned to the study
- Providing feedback to line managers on staff performance
The ideal candidate will have:
- A 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
- Preferred experience with risk-based monitoring
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills
- Good communication, presentation, and interpersonal skills
- Strong conflict resolution skills
- Moderate travel may be required, approximately 20%