Clinical Trial Manager

Clinical Trial Manager 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. Oversight of site interactions post activation through site closeout, including patient recruitment, investigator payments, and related activities. May also identify critical data/process risks and develop mitigations related to RACT.
• Reviews study scope of work, budget and protocol to ensure the clinical project team (CRAs/CeMs) is aware of contractual obligations and parameters. Uses prior experience, data, metrics and reports to identify risks and escalates them to the project manager.
• Applies strategic thinking and problem‑solving skills to propose and implement risk mitigations, and participates in key meetings such as Kick‑Off.
• Serves as an escalation point for communication with investigator site staff and may interact by phone or in person with principal investigators or other site staff. May accompany CRA team members to sites for observation or conflict resolution.
• Collaborates with Study Start‑Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet milestones such as site activation, enrollment and database lock timelines. Provides feedback on functional plans (e.g. Data Management Plan, Communication Plan).
• Creates and maintains clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are ready for use and oversees user acceptance testing.
• Coordinates training for the study team on protocol specifics, CRF completion, dashboards, SOPs, clinical plans and guidelines, and data timelines.
• Manages resourcing allocations for CRAs and Central Monitors, site assignments and staff conduct, identifying delivery or quality risks and ensuring deliverables meet quality standards.
• Reviews dashboards and clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, dashboards) to monitor site and patient activities, ensuring data updates align with the plan.
• Partakes in monitoring strategy development and ensures team members understand and comply with the monitoring strategy and risk plans.
• Reviews site and central monitoring documentation to ensure accurate representation of activities and risk communication; documents revisions and approvals in CTMS.
• Provides status updates and solutions for obstacles in protocol execution and site management to clients, project management and leadership.
• Ensures cross‑functional compliance with SOPs, ICH GCP, and local regulations and supports inspection readiness.
• Oversees CRAs and Central Monitors, assessing training compliance and identifying emerging risks; develops corrective action plans and supports data cut and lock deadlines.
• Provides feedback to line managers on staff performance and development areas.
• May be assigned to larger, more complex trials or coordinate activities for a portfolio of projects.
• May coach and mentor CTMs regarding functional delivery, risk evaluation and action implementation.

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience.
• Demonstrated ability to lead and align teams toward project milestones.
• Experience working in an international environment.
• Expertise in site management and monitoring (clinical or central).
• Experience with risk‑based monitoring preferred.
• Understanding of financial principles and budget management for clinical trial management.
• Knowledge of Good Clinical Practice, ICH Guidelines and applicable regulatory requirements.
• Strong computer skills.
• Strong conflict resolution skills.
• Problem‑solving and risk‑management approach to complex issues.
• Critical thinking for identifying causes and appropriate solutions.
• Moderate travel (approximately 20%) may be required.

Salary Range: $ – $. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on experience, skills and proficiency.

Benefits may include a company car or allowance, Health benefits…