Senior Clinical Trial Manager – LATAM

This is a fully remote position, open to applicants in Brazil, +2 more countries.

📋 Description

• Act as the main clinical point of contact for the client.

• Take ownership of the planning, execution, and oversight of clinical studies while ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory standards.

• Work closely with the Project Manager to manage monthly invoicing and clinical budget variances.

• Create clinical study documents, plans, informed consent templates, study forms and manuals, CRF completion guidelines, trackers, presentation slides, and training materials.

• Identify and provide study-specific training for Clinical Research Associates (CRAs) and third-party vendors.

• Generate potential site lists and lead site feasibility assessments.

• Recognize enrollment risks and formulate recruitment and retention strategies for various countries.

• Oversee feasibility, site start-up, enrollment, maintenance, and close-out processes.

• Facilitate internal clinical team meetings and establish expectations for CRAs and Clinical Trial Assistants (CTAs).

• Address inquiries from CRAs and sites while maintaining FAQ logs.

• Support investigator meetings and review or approve investigational product release packages.

• Manage submissions and approvals with Competent Authorities and IRB/Ethics Committees.

• Develop strategies for clinical monitoring and track study timelines and quality deliverables.

• Generate and utilize metrics reports, including CTMS, DM query trends, and outstanding monitoring reports.

• Implement and manage the electronic Trial Master File (eTMF).

• Collaborate with Project Managers, CRAs, and Quality Assurance on CAPA plans and ensure timely resolutions.

• Assist sites, internal teams, and CRAs in preparing for GCP audits.

• Partner with the Project Manager on project-specific resourcing challenges and escalate issues related to CRA performance or site compliance.

• Collaborate with data management and CRAs to ensure data quality and adherence to cleaning timelines.

• Oversee investigational product processes, including accountability and reconciliation.

• Assume project management duties when a cross-functional PM is not available.

• Support business development and marketing efforts.

• Potentially negotiate site budgets and investigator contracts.

• Potentially review site visit reports and monitor execution of plans.

• Potentially manage clinical vendors.

• Potentially conduct clinical data reviews and generate queries.

• Potentially hold line management responsibilities.

• Perform additional tasks as assigned by management.

⛳️ Requirements

• Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field.

• At least 7 years of clinical research experience or demonstrated competencies for the position, with substantial clinical monitoring experience.

• Professional working proficiency in English is required.

• Proficient in Microsoft Office Products (Outlook, Word, Excel, PowerPoint).

• Willingness to travel domestically and internationally, including overnight stays.

• In-depth knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with the ability to implement them.

• Familiarity with clinical management techniques and tools.

• Direct experience in a cross-functional work environment.

• Proven track record in functional management and delegation while promoting cohesive team dynamics.

• Demonstrated experience in planning, risk management, and change management.

• Extensive experience in pharmaceutical and/or device research is required.

• Proven ability in independent negotiation and conflict management strategies.

• Advanced degree is preferred.

🏝️ Benefits

• Opportunities for career advancement, including the chance to build teams, establish processes, influence organizational culture, and take on broader leadership and project management roles.

• Regular full-time employment.