Clinical Trial Manager ll​/Sr. Hybrid- or Home based

Overview

Clinical Trial Manager II / Senior. Hybrid- or Home-based role.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient. We collaborate across environments to simplify and streamline work, accelerate therapy delivery, and change lives.

• Roles within the Clinical Trial Management family are responsible for all aspects of development, coordination, and implementation of Phase 1 clinical research studies at the organization’s facilities.
• Collaborate with the principal investigator and act as a liaison among research subjects, client teams, investigators, and clinic operations; plan logistics and resource usage.
• Track study progress in alignment with project milestones, client deliverables, and budget, and ensure compliance with applicable regulations globally and by region.
• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversee site interactions post-activation through site closeout, including patient recruitment or other related activities. Identify critical data and process risks and mitigations related to the Risk Assessment and Categorization Tool (RACT).
• Review the study scope of work, budget, and protocol content; ensure the clinical project team is aware of contractual obligations and parameters. Use experience, metrics, and reports to identify risks to deliverables; escalate risks to the project manager as needed.
• Apply strategic thinking and problem-solving to propose risk mitigations; participate in key meetings such as Kick Off Meetings.
• Serve as an escalation point for communications with investigator site staff and interact with principal investigators or site staff as required. May accompany CRA team members to sites for observation or conflict resolution.
• Coordinate with Study Start Up, Patient Recruitment, and Data Management to meet milestones (site activation, enrollment, and database lock). Review and provide feedback on functional plans related to trial management activities.
• Develop and maintain clinical study tools and templates (e.g., Clinical Monitoring Plan); ensure CTMS, dashboards and systems are set up and accessible, including user acceptance testing (UAT) as needed; ensure access and audit trails are reviewed.
• Coordinate training for the study team on protocol specifics, CRF completion, dashboards, SOPs, data plans, and timelines.
• Oversee resource allocations for CRAs and Central Monitors, site assignments, and team conduct; identify risks to delivery or quality and maintain progress visibility through approved systems or tracking tools.
• Review project oversight dashboards and systems (CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data reflects timely execution of required visits and activities.
• Understand monitoring strategy and participate in development of the study risk assessment plan; ensure team understanding and compliance with CMP/SMP and risk plans.
• Review the quality of site and central monitoring documentation; ensure they reflect site management activities and convey risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity. Document revisions in CTMS and meet deadlines.
• Interact with the client and other functional departments to provide status updates on deliverables and risks; propose solutions to obstacles in protocol execution and site management.
• Demonstrate understanding of other functions’ roles to achieve protocol compliance and delivery; support inspection readiness for clinical trial management scope.
• Oversee CRAs and Central Monitors, assess process and training compliance, and develop corrective action plans as needed; support data cut and lock deadlines.
• Provide feedback to line managers on staff performance and development needs.
• May be assigned to…