Clinical Trial Manager II, Regulatory Experience

Syneos Health

. Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity .

Posted 9/25/2026full-timeRemote • ArgentinaMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity
Oversee site interactions from activation through closeout, including patient recruitment and investigator payments
Identify critical data, process risks, protocol execution risks and risk mitigations
Review study scope, budget and protocol content and communicate contractual obligations to the clinical project team
Identify and escalate risks to timelines, quality, budget and contracted scope
Propose and implement risk mitigations
Participate in and present at key meetings, including Kick Off Meetings
Serve as an escalation point for investigator site communications and interact with principal investigators and site staff
Coordinate delivery handoffs with Study Start Up, Patient Recruitment and Data Management
Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
Ensure CTMS, dashboards and other systems are configured and available, including user acceptance testing and access/audit trail reviews
Coordinate training for study teams on protocols, CRFs, dashboards, SOPs, plans and timelines
Oversee CRA and Central Monitor resourcing, site assignments and study team conduct
Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables
Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards
Oversee compliance with monitoring strategies, CMP/SMP and risk plans
Review monitoring documentation and ensure revisions, approvals and deliverables meet company and sponsor specifications
Interact with clients and functional departments and provide status updates on deliverables and risks
Support inspection readiness for clinical trial management scope
Oversee CRAs and Central Monitors, assess compliance and emerging risks, and support corrective action plans
Support activities to achieve data cut and lock deadlines
Provide staff performance feedback to line managers
May be assigned to larger, more complex trials

Requirements

What you’ll need

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
Understanding of clinical trial management financial principles and budget management
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Good computer skills
Good communication, presentation and interpersonal skills among project team and with sites
Strong conflict resolution skills
Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach
Critical thinking to determine causes and appropriate solutions
Moderate travel may be required, approximately 20%

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate