Description
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
The Clinical Trial Manager II role 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:
- Oversees site interactions post-activation through site closeout
- Identifies critical data and processes, protocol execution risks, and risk mitigations
- Reviews study scope of work, budget, and protocol content
- Uses prior clinical experience, operational data, metrics, and reports to identify risks
- Escalates risks to clinical trial management deliverables to the project manager
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
- Participates in key meetings and serves as an escalation point for communications with investigator site staff
- Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones
- Develops and maintains clinical study tools and templates
- Coordinates training to the study team
- Oversees resourcing allocations for CRAs and Central Monitors
- Ensures quality of clinical monitoring, central monitoring, and site management deliverables
- Reviews project oversight dashboards and other clinical trial systems
- Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan
- Reviews content and quality of site and central monitoring documentation
- Interacts with clients and other functional departments related to clinical monitoring, central monitoring, and site management activities
- Demonstrates understanding of other functions' roles in achieving compliance and delivery
- Oversees CRAs and Central Monitors assigned to the study
- Provides 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
- 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 to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%