Senior Clinical Trial Manager – LATAM

Precision For Medicine

. Serve as the primary clinical point of contact with the client .

Posted 10/14/2026full-timeRemote • Brazil, Colombia, MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical research management, including planning, execution, and oversight of clinical studies in compliance with ICH-GCP and regulatory requirements. Proficient in developing clinical study documents and managing cross-functional teams to ensure data quality and compliance.

Highest-signal resume keywords

Clinical Research ManagementICH-GCP ComplianceClinical Study DocumentationRisk ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringStudy Feasibility AssessmentData Quality ManagementClinical Trial Management System (CTMS)Electronic Trial Master File (eTMF)Regulatory SubmissionsBudget ManagementNegotiation SkillsClinical Data ReviewChange Management

Soft Skills

Team LeadershipConflict ManagementEffective CommunicationTraining and DevelopmentProblem Solving

Tools & Technologies

Microsoft Office ProductsClinical Management ToolsMetrics Reporting Tools

Industry Keywords

Clinical ResearchPharmaceutical ResearchDevice ResearchSOPsRegulatory Guidance

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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