[Hiring] Senior Clinical Trial Manager @Syneos Health

Role Description

The Senior Clinical Trial Manager (Sr. CTM) serves as the clinical functional lead, accountable for the delivery of site management, clinical monitoring, and central monitoring of assigned study(ies). The position provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to ensure compliance with the monitoring plan and ensures timeliness and quality of deliverables within the specified budget. The Senior CTM may provide direction, oversight, and coordination of CTM(s) working across regions and/or countries to ensure clinical project and site deliverables are met.

Job Responsibilities

• Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Oversees site interactions post-activation through site closeout, including patient recruitment and investigator payments.
• Identifies critical data and process, protocol execution risks, and risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget, and protocol content, ensuring the clinical project team is aware of contractual obligations.
• Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.
• Escalates risks to clinical trial management deliverables (timeline, quality, and budget) to the project manager.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• 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.
• Reviews and provides feedback on other functional plans as they relate to clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates.
• Ensures CTMS, dashboards, and other systems are set up and available for use by the clinical team.
• Coordinates initial and ongoing training to the study team regarding protocol specificities and clinical plans.
• 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.
• 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 and site management activities.
• Provides status updates on clinical deliverables and risks to clients, project management, and leadership.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol.
• Oversees CRAs and Central Monitors assigned to the study and assesses study-specific process compliance.
• Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance.
• May be assigned to larger, more complex trials or coordinate clinical activities for a team of CTMs.
• May coach and mentor CTMs regarding functional clinical delivery and risk evaluation.

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.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem-solving techniques to resolve complex issues.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its sole discretion. Equivalent experience, skills, and/or education will also be considered. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate.