Description
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. The Clinical Trial Manager 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.
Responsibilities:
- Responsible for site management oversight, clinical monitoring, and central monitoring deliverables
- Oversees site interactions post-activation through site closeout
- May be responsible for identification of critical data and process, protocol execution risks, and risk mitigations
- Reviews the study scope of work, budget, and protocol content
- Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables
- Escalates to the project manager any risks to clinical trial management deliverables
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
- Participates and presents in key meetings
- 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
- Responsible for development and ongoing maintenance of clinical study tools and templates
- Coordinates initial and ongoing training to the study team
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct
- Ensures quality of the clinical monitoring, central monitoring, and site management deliverables
- Reviews the 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 the content and quality of site and central monitoring documentation
- Interacts with the client and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables
- Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations
- Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance
- 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 (clinical or central)
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Good communication, presentation, and interpersonal skills among project team and with sites
- 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%