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 study documents, plans, informed consent templates, study forms and manuals, CRF completion guidelines, trackers, presentation slides, and training materials
• Identify and deliver study-specific training for CRAs and third-party vendors
• Generate potential site lists and lead site feasibility
• Identify enrollment risks and develop country recruitment and retention strategies
• Manage 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 FAQ logs
• Support investigator meetings and review or approve investigational product release packages
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies and track study timelines and quality deliverables
• Generate and use metrics reporting, including CTMS, DM query trends, and outstanding monitoring reports
• Implement and manage the electronic Trial Master File (eTMF)
• Collaborate with PM, CRAs, and QA on CAPA plans and ensure timely closure
• Assist sites, internal staff, and CRAs with GCP audit preparation
• Work with the PM on project-specific resourcing issues and escalate CRA performance or site compliance issues
• Collaborate with data management and CRAs to ensure data quality and 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
• Potentially negotiate site budgets and investigator contracts
• Potentially review site visit reports and monitoring-plan execution
• Potentially manage clinical vendors
• Potentially perform clinical data review and query generation
• Potentially have line management responsibilities
• Perform other duties assigned by management

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field
• 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 and delegation while fostering cohesive team dynamics
• Proven experience in 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
• Advanced degree preferred

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