Senior Clinical Trial Manager – LATAM

• Serve as the primary clinical point of contact with the client
• Own planning, execution, and oversight of clinical studies in compliance with protocol, SOPs, ICH-GCP, and regulatory requirements
• Collaborate with the Project Manager on monthly invoicing and clinical budget variance management
• Develop clinical documents, including clinical plans, informed consent form templates, study-specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and training materials
• Identify training needs for CRAs and third-party vendors and present training at Investigator Meetings and Study Kick-off meetings
• Generate potential site lists and drive site feasibility
• Identify enrollment risks and develop country recruitment and retention strategies
• Coordinate feasibility, site start-up, enrollment, maintenance, and close-out procedures
• Lead internal clinical team meetings and set expectations for CRAs and CTAs
• Address CRA and site questions and maintain the FAQ log
• Support planning and conduct of investigator meetings
• Review and/or approve investigational product release packages
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies and ensure study timelines and quality deliverables
• Generate and use metric reporting, including CTMS, data-management query trends, and outstanding monitoring reports
• Implement and manage the eTMF
• Develop and implement CAPA plans with PM, CRAs, and QA
• Assist sites, internal staff, and CRAs with GCP audit preparation
• Coordinate project-specific resourcing issues with the PM
• Escalate CRA performance and site compliance issues
• Collaborate with data management and CRAs to ensure data quality and data-cleaning timelines
• Manage investigational product processes, including drug accountability and reconciliation
• Assume project management responsibilities when a cross-functional PM is not assigned
• Support business development and marketing activities
• Negotiate site budgets and investigator contracts as needed
• Review site visit reports and ensure monitoring is conducted according to the monitoring plan
• Manage clinical vendors as needed
• Perform clinical data review of patient profiles, data listings, and summary tables, including query generation
• Potentially manage direct reports
• Perform other duties assigned by management

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
• Professional working proficiency in English required
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Ability to travel domestically and internationally, including overnight stays
• Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross-functional environment
• Proven experience in functional management, delegation, planning, risk management, and change management
• In-depth proven experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies
• Excellent communication, organizational, presentation, analytical, interpersonal, time management, decision-making, and critical-thinking skills

• Career growth opportunities, including opportunities to build teams, define processes, influence culture, and step into broader leadership and project management responsibilities
• Regular full-time employment