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 liaison with the client.

• Take charge of the planning, execution, and oversight of clinical studies while adhering to protocol, SOPs, ICH-GCP, and regulatory standards.

• Partner with the Project Manager on monthly invoicing and management of clinical budget variances.

• Create clinical documents such as clinical plans, templates for informed consent forms, study-specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV presentations, and training materials.

• Assess training requirements for CRAs and third-party vendors, and deliver training during Investigator Meetings and Study Kick-off meetings.

• Develop potential site lists and drive site feasibility assessments.

• Identify enrollment challenges and formulate strategies for country recruitment and retention.

• Oversee feasibility assessments, site initiation, enrollment, maintenance, and closure procedures.

• Lead internal clinical team meetings and establish expectations for CRAs and CTAs.

• Respond to CRA and site inquiries while maintaining the FAQ log.

• Assist in the planning and execution of investigator meetings.

• Review and/or authorize investigational product release packages.

• Supervise submissions and approvals to Competent Authorities and IRB/Ethics Committees.

• Establish clinical monitoring strategies to ensure adherence to study timelines and high-quality deliverables.

• Generate and utilize metric reports, including CTMS, data-management query trends, and outstanding monitoring reports.

• Implement and oversee the eTMF.

• Develop and execute CAPA plans in collaboration with PM, CRAs, and QA.

• Aid sites, internal personnel, and CRAs in GCP audit preparations.

• Coordinate project-specific resource issues with the PM.

• Raise concerns regarding CRA performance and site compliance as necessary.

• Work together with data management and CRAs to ensure data integrity and meet data-cleaning deadlines.

• Manage investigational product processes, including drug accountability and reconciliation.

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

• Assist in business development and marketing efforts.

• Negotiate site budgets and investigator contracts as required.

• Review site visit reports to ensure monitoring aligns with the established monitoring plan.

• Manage clinical vendors as necessary.

• Conduct clinical data reviews of patient profiles, data listings, and summary tables, including generating queries.

• Potentially oversee direct reports.

• Perform additional duties as assigned by management.

⛳️ Requirements

• Bachelor’s degree or a combination of education and experience in a science or health-related field; advanced degree preferred.

• At least 7 years of clinical research experience or demonstrable competencies for the role with substantial clinical monitoring experience.

• Professional working proficiency in English is required.

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

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

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

• Familiarity with clinical management techniques and tools.

• Direct work experience in a cross-functional setting.

• Proven expertise in functional management, delegation, planning, risk management, and change management.

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

• Demonstrated ability in independent negotiation and conflict resolution strategies.

• Exceptional communication, organizational, presentation, analytical, interpersonal, time management, decision-making, and critical-thinking skills.

🏝️ Benefits

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

• Regular full-time employment.