Clinical Trial Manager II - Remote

About the role

Syneos Health is hiring a Clinical Trial Manager II for a remote position. The role oversees site management, clinical monitoring and central monitoring, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. It covers site interactions from post-activation through closeout, and may involve larger, more complex trials.

Key responsibilities

• Review the study scope, budget and protocol, and escalate risks to the project manager (timeline, quality, budget) and out-of-scope requests.
• Identify risks to clinical trial management deliverables using prior experience, operational data and metrics, and propose and implement risk mitigations.
• Escalate to the project manager and act as an escalation point for communications with investigator site staff, including accompanying CRA team members to sites.
• Coordinate handoffs with Study Start Up, Patient Recruitment and Data Management, and review plans such as the Data Management Plan and Communication Plan.
• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan, and set up CTMS, dashboards and other systems, including UAT.
• Oversee resourcing of CRAs and Central Monitors, site assignments and study team conduct, and review project oversight dashboards (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS).
• Ensure quality of monitoring and site management deliverables, review site and central monitoring documentation, and document revisions in CTMS.
• Provide status updates and solutions to the client and leadership, and support inspection readiness.
• Support data cut and lock deadlines, and provide feedback to line managers on staff performance.

Required profile

• 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 and to work in an international environment.
• Preferred experience with risk-based monitoring.
• Modest travel may be required, approximately 20%.

Required skills

• Expertise in site management and monitoring (clinical or central)
• Understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
• Good computer skills, communication, presentation and interpersonal skills, and strong conflict resolution skills