Clinical Trial Manager – Project Management, Sponsor Dedicated

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables, with an emphasis on patient safety, compliance with protocols/GCP/regulatory standards, and maintaining data integrity.

• Manages site interactions from activation through to site closure.

• Responsibilities may include patient recruitment, overseeing investigator payments, and other related tasks.

• May involve identifying critical data and processes, assessing protocol execution risks, and implementing risk mitigations associated with the Risk Assessment and Categorization Tool (RACT).

• Reviews the study's scope of work, budget, and protocol content, ensuring the clinical project team (CRAs/Central Monitors) is informed of contractual obligations and parameters.

• Utilizes prior clinical experience, operational data, metrics, and reports to pinpoint risks to clinical trial management deliverables.

• Communicates any risks to clinical trial management deliverables (timelines, quality, and budget) to the project manager, along with activities and requests that fall outside the contracted scope.

• Employs strategic thinking and problem-solving abilities to suggest and implement risk mitigations.

• Actively participates and presents in essential meetings such as the Kick-Off Meeting.

• Acts as a point of escalation for communications with investigator site staff and may need to interact directly with principal investigators or other site personnel, either by phone or in person.

• May include accompanying CRA team members to sites for observation or conflict resolution purposes.

• Collaborates with other functional leaders, such as Study Start-Up, Patient Recruitment, and Data Management, to ensure smooth delivery handoffs and meet study milestones like site activation targets, enrollment goals, and database lock timelines.

• Reviews and provides input on other functional plans (e.g., Data Management Plan, Communication Plan) concerning clinical trial management activities.

• Responsible for developing and maintaining clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensures CTMS, dashboards, and other systems are properly set up and accessible for the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Guarantees that access and audit trail reviews are conducted as required.

• Coordinates initial and ongoing training for the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, and timelines for the study.

• Oversees resource allocations for CRAs and Central Monitors, site assignments, and the conduct of study team members while identifying risks to delivery or quality.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project, maintaining proper visibility of progress through approved systems and tracking tools.

• Reviews project oversight dashboards and other clinical trial systems (e.g., Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities, study team conduct, and ensure data is updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.

• Understands the necessary monitoring strategy for the study and, where needed, contributes to developing the study risk assessment plan.

• Holds accountability for their assigned clinical team members' understanding, ongoing compliance, and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.

• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence) to ensure they accurately reflect site management activities, convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS.

• Ensures that these deliverables are provided in accordance with company and/or sponsor specifications, including delivery deadlines.

• Engages with clients and other functional departments regarding clinical monitoring, central monitoring, and site management activities and deliverables.

• Provides status updates on clinical deliverables and risks to clients, project management, and leadership as per departmental or study agreements.

• Offers solutions to challenges in protocol execution and site management.

• Demonstrates an understanding of the roles of other functions in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and national regulations.

• Supports Inspection Readiness for the scope of clinical trial management.

• Oversees CRAs and Central Monitors assigned to the study and routinely evaluates study-specific process and training compliance, CMP compliance, while identifying emerging risks.

• May develop and support the execution of corrective action plans at both site and study levels.

• Supports and completes activities to meet data cut and lock deadlines.

• Provides feedback to line managers concerning staff performance, highlighting both strengths and areas for improvement.

• May be assigned to larger, more complex trials.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams to achieve project milestones.

• Demonstrated capability to work in an international environment.

• Proven expertise in site management and monitoring (clinical or central).

• Preferred experience in risk-based monitoring.

• Solid understanding of clinical trial management financial principles and budget management.

• Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must possess strong computer skills.

• Excellent communication, presentation, and interpersonal skills among project teams and with sites.

• Strong conflict resolution abilities.

• Proven ability to apply problem-solving techniques to address complex issues and adopt a risk management approach to identify and mitigate potential threats to the successful execution of a clinical research project.

• Demonstrates critical thinking to ascertain the cause and appropriate solution in identifying issues.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• We are dedicated to developing our people through career advancement and progression;

• supportive and engaged line management;

• technical and therapeutic area training;

• peer recognition and a comprehensive rewards program.

• We are committed to fostering an inclusive culture – where you can truly be yourself.