Clinical Trial Manager II

Syneos Health is seeking a Clinical Trial Manager II to join their team.

The Clinical Trial Manager II is 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
• Demonstrated ability to apply problem-solving techniques to resolve complex issues
• Critical thinking skills
• Moderate travel may be required, approximately 20%

Syneos Health offers a range of benefits, including a company car or car allowance, health benefits, company match 401k, eligibility to earn commissions/bonus, and flexible paid time off.