Description
Syneos Health is seeking a Clinical Trial Manager II to oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol compliance, and data integrity.
The successful candidate will be responsible for:
- Site management oversight, including site interactions post-activation and site closeout
- Clinical monitoring and central monitoring deliverables
- Identification of critical data and processes, protocol execution risks, and risk mitigations
- Review of study scope of work, budget, and protocol content
- Collaboration with cross-functional teams, including CRAs, Central Monitors, and Study Start Up
- Strategic thinking and problem-solving to propose and implement risk mitigations
- Participation in key meetings, such as Kick Off Meetings
- Escalation point for communications with investigator site staff
- Development and maintenance of clinical study tools and templates
- Coordination of training for the study team
- Oversight of resourcing allocations for CRAs and Central Monitors
- Review of project oversight dashboards and clinical trial systems
The ideal candidate will have:
- A Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Demonstrated expertise in site management and monitoring (clinical or central)
- 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
- Strong communication, presentation, and interpersonal skills
- Conflict resolution skills
- Critical thinking and problem-solving skills
Benefits of working at Syneos Health include:
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture