Clinical Trial Manager II - Sponsor Dedicated - Chile Home Based

Syneos Health is seeking a Clinical Trial Manager II - Sponsor Dedicated to work remotely from Chile.

The Clinical Trial Manager II - Sponsor Dedicated 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, including patient recruitment, investigator payments, and other related activities
• Identifies critical data and processes, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews study scope of work, budget, and protocol content to ensure clinical project team awareness of contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables
• 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, such as Kick Off 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, including the Clinical Monitoring Plan
• Coordinates training to the study team regarding protocol specificities, Case Report Form (CRF) completion, and Sponsor Standard Operating Procedures (SOPs)
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct
• Ensures quality of clinical monitoring, central monitoring, and site management deliverables
• Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct, and data updates
• 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 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 assesses study-specific process and training compliance
• Provides feedback to line managers on staff performance

Requirements:

• 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
• 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%