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Precision Medicine Group is seeking a Senior Clinical Trial Manager to lead and build clinical operations across Latin America, supporting rapid growth in Mexico, Brazil, Argentina, Colombia, Chile, and Peru.
In this role, you will serve as the primary clinical point of contact with clients and own the planning, execution, and oversight of clinical studies. You will ensure delivery in compliance with protocol, SOPs, ICH-GCP, and regulatory requirements. Key responsibilities include:
• Shape country-level recruitment strategies and lead feasibility and site start-up processes
• Develop study-related clinical documents including clinical plans, informed consent form templates, case report forms, and training materials
• Identify and develop training needs for Clinical Research Associates (CRAs) and third-party vendors, presenting at investigator meetings and study kick-off meetings
• Generate potential site lists and drive the site feasibility process, identifying enrollment risks
• Lead internal clinical team meetings, set expectations for CRAs and Clinical Trial Associates, and mentor team members as the region scales
• Develop and implement clinical monitoring strategies to ensure study timelines and quality deliverables
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments
• Manage investigational product processes including drug accountability and reconciliation
• Generate metric reporting (CTMS, data management query trends, monitoring reports) to track study progress
• Manage eTMF implementation and collaborate on Corrective and Preventative Action Plans (CAPA)
• Support GCP audit preparation and assist with site visit report reviews
• Collaborate with Project Managers on budget management, invoicing, and variance analysis
• May assume project management responsibilities when a cross-functional PM is not assigned
• May have line management responsibilities and negotiate site budgets and investigator contracts
This role offers significant career growth opportunities, including building teams, defining processes, influencing culture, and stepping into broader leadership responsibilities as the region expands.
REQUIREMENTS:
• In-depth proven experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies
• [Note: The posting excerpt indicates additional qualifications exist but were omitted from the provided text]
