Clinical Trial Manager II - Mexico Remote

About the role

Syneos Health is hiring a Clinical Trial Manager II for a remote position based in Mexico. The role oversees site management, clinical monitoring and central monitoring, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. It may cover larger, more complex trials or coordinate clinical activities for a team of CTMs across a portfolio.

Key responsibilities

• Oversee site interactions from post-activation through closeout, including patient recruitment and investigator payments
• Identify risks to clinical trial management deliverables and escalate them to the project manager; propose and implement risk mitigations
• Take part in key meetings such as the Kick Off Meeting and act as an escalation point for investigators and site staff
• Collaborate with Study Start Up, Patient Recruitment and Data Management to meet milestones such as site activation, enrollment and database lock targets
• Maintain clinical study tools and templates, including the Clinical Monitoring Plan, and set up CTMS, dashboards and systems, including UAT
• Coordinate training for the study team on protocol, CRFs, SOPs and timelines, and oversee resourcing of CRAs and Central Monitors
• Review monitoring documentation and site visit reports, document requested revisions in CTMS and provide status updates to the client and leadership
• Support inspection readiness, data cut and lock, and develop corrective action plans
• Provide feedback to line managers on staff performance and may coach and mentor CTMs

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
• 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
• Good computer skills, strong conflict resolution skills and a risk management approach to complex issues
• Modest travel may be required, approximately 20%

Required skills

• Knowledge of Good Clinical Practice (ICH GCP) and other applicable regulatory requirements
• Preferred: risk-based monitoring