Senior Clinical Trial Manager – LATAM

Precision Medicine Group

. 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 compliance with ICH-GCP and regulatory requirements, as well as proficiency in developing clinical documents and managing clinical studies. Strong capabilities in project management, negotiation, and communication are essential for success in this role.

Highest-signal resume keywords

Clinical Research ManagementICH-GCP ComplianceClinical Document DevelopmentProject ManagementNegotiation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringData ManagementRisk ManagementCAPA ImplementationClinical Study ExecutionSite Feasibility AssessmentInvestigational Product ManagementMetric ReportingClinical Budget ManagementRegulatory Submissions

Soft Skills

Excellent CommunicationOrganizational SkillsAnalytical SkillsInterpersonal SkillsDecision-Making Skills

Tools & Technologies

Microsoft Office ProductsCTMSETMF

Industry Keywords

Clinical ResearchPharmaceutical ResearchDevice ResearchSOPsInvestigator Meetings

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 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

Requirements

What you’ll need

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

Benefits

Comp & perks

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