Clinical Research

• 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

Clinical Trial Manager II, Regulatory Experience

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders

Clinical Research jobs in Argentina

Clinical Trial Manager II, Regulatory Experience

Senior Clinical Research Associate