Remote Clinical Trial Manager II - Sponsor Dedicated (Chile)

Syneos Health, Inc.; Chile; Remote; CLP 12,000,000 - 18,000,000; Full time

Job summary

Syneos Health, Inc. is seeking a Clinical Trial Manager II to be sponsor-dedicated and home-based in Chile.

You will oversee site management, clinical and central monitoring with a focus on patient safety, data integrity and regulatory compliance. You will guide the study team, manage risks via RACT, coordinate trainings, and ensure milestones are met through CTMS/EDC systems while collaborating with cross-functional leaders.

Responsibilities

• Site management oversight, clinical monitoring and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions from activation through site closeout, including patient recruitment or other related activities.
• Identifies critical data and process risks and mitigations related to RACT (Risk Assessment and Categorization Tool).
• Reviews scope of work, budget and protocol content; ensures the clinical project team (CRAs/Central Monitors) understands contractual obligations and parameters.
• Uses operational data and metrics to identify risks to clinical trial management deliverables.
• Escalates risks to the project manager for timeline, quality and budget concerns and for out-of-scope activities.
• Employs strategic thinking to propose and implement risk mitigations.
• Participates in key meetings such as Kick Off Meeting.
• Acts as escalation point for communications with investigator site staff and may interact with principal investigators or site staff.
• Coordinates training for the study team on protocol specifics, CRF completion, dashboards, SOPs and data plans.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and team conduct, identifying risks to delivery or quality.
• Ensures quality of monitoring and site management deliverables and maintains project visibility with approved systems and tracking tools.
• Reviews project oversight dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee progress.

Job description

Syneos Health, Inc. is seeking a Clinical Trial Manager II to be sponsor-dedicated and home-based in Chile.

You will oversee site management, clinical and central monitoring with a focus on patient safety, data integrity and regulatory compliance. You will guide the study team, manage risks via RACT, coordinate trainings, and ensure milestones are met through CTMS/EDC systems while collaborating with cross-functional leaders.