Description
Syneos Health is seeking a Clinical Trial Manager - Full Service. As a Clinical Trial Manager, you 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:
- Oversee site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities.
- Review study scope of work, budget, and protocol content, ensuring the clinical project team is aware of contractual obligations and parameters.
- Employ strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Serve as an escalation point for communications with investigator site staff.
- Collaborate with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
- Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.
- Coordinate training for the study team regarding protocol specificities, Case Report Form completion, and Sponsor Standard Operating Procedures.
- Oversee resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct.
- Review project oversight dashboards and other clinical trial systems to ensure data has been updated to reflect timely execution of all operational aspects.
- Understand the monitoring strategy required for the study and participate in the development of the study risk assessment plan.
- Review content and quality of site and central monitoring documentation.
- Interact with clients and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables.
- Demonstrate understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.
- Oversee CRAs and Central Monitors assigned to the study and assess study-specific process and training compliance.
- Provide 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.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Strong conflict resolution skills.
- Moderate travel may be required, approximately 20%.