Clinical Trial Manager with focus on Project Management - Sponsor dedicated - Brazil Home Based

• Clinical Trial Manager – Project Management – Sponsor Dedicated – Brazil Home Based
• Job Responsibilities
• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout, including patient recruitment and investigator payments.
• May identify critical data and process, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
• Review the study scope of work, budget and protocol content and ensure the clinical project team (CRAs/Central Monitors) is aware of contractual obligations.
• Use prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalate to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities outside contracted scope.
• Employ strategic thinking and problem‑solving skills to propose and implement risk mitigations.
• Participate and present in key meetings such as Kick‑Off Meetings.
• Serve as an escalation point for communications with investigator site staff and may interact on the phone or in person with principal investigators or other site staff members, inclusive of accompanying CRA team members for observation or conflict resolution.
• Collaborate with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones (site activation targets, enrollment targets, database lock timelines).

Review and provide feedback on other functional plans (e. g., Data Management Plan, Communication Plan).

• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.

Ensure CTMS, dashboards and other systems are set up and available for use, including overseeing user acceptance testing as needed, and conduct access and audit trail reviews.

• Coordinate initial and ongoing training for the study team regarding protocol specificities, CRF completion, dashboards, Sponsor SOPs, clinical plans and guidelines, and data timelines.
• Oversee resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct, and identify risks to delivery or quality.
• Ensure quality of the clinical monitoring, central monitoring and site management deliverables within the project and maintain proper visibility of progress via approved systems and tracking tools.
• Review project oversight dashboards and other clinical trial systems (e. g., CTMS, EDC, e Diary, e PROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities, study team conduct and confirm timely operational execution.
• Understand the monitoring strategy required for the study; where required, participate in developing the study risk assessment plan and ensure assigned clinical team members' understanding and compliance according to monitoring strategy, CMP/SMP and risk plans.
• Review the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports, pertinent correspondence) to ensure they represent site management activities, conduct and appropriately convey risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
• Interact with the client and other functional departments related to monitoring, central monitoring and site management activities and deliverable status updates on risks to clients, project management and leadership.
• Demonstrate understanding of other functions’ roles in achieving compliance and delivery (data management, study start‑up, patient recruitment, medical monitoring, pharmacovigilance, QA).

Support Inspection Readiness for clinical trial management scope.

• Oversee CRAs and Central Monitors assigned to the study and routinely assess study‑specific process and training compliance, CMP compliance and identify emerging risks.

Develop and support corrective action plans at site and study level and complete activities to achieve data cut and lock deadlines.

• Provide feedback to line managers on staff performance including strengths and areas for development. May be assigned to larger, more complex trials.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrated expertise in site management and monitoring (clinical or central).
• Preferred experience with risk‑based monitoring.
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills.
• Good communication, presentation and interpersonal skills among project team and with sites.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem‑solving techniques to resolve complex issues, and apply a risk‑management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20 %.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive.

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