Clinical Trial Manager – Project Management

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/regulations, and data integrity.

• Manages site interactions from activation through to closeout, which may involve patient recruitment, investigator payments, and other related tasks.

• May oversee the identification of critical data, processes, protocol execution risks, and risk mitigation strategies as part of the Risk Assessment and Categorization Tool (RACT).

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

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

• Escalates any risks to clinical trial management deliverables (including timeline, quality, and budget) as well as any activities and requests that fall outside of the contracted scope to the project manager.

• Applies strategic thinking and problem-solving skills to suggest and implement risk mitigation strategies.

• Participates in and presents at key meetings, such as the Kick Off Meeting.

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

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

• Reviews and provides feedback on other functional plans (e.g., Data Management Plan, Communication Plan) as they pertain to clinical trial management activities.

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

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

• Ensures access and audit trail reviews are performed 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, identifying any risks to delivery or quality.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project while maintaining visibility into its progress through approved systems and/or 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 supervise site and patient activities, study team conduct, and ensure data reflects timely execution of all operational aspects (required visits/calls, duration, and frequency) in accordance with the plan.

• Understands the monitoring strategy necessary for the study and participates in developing the study risk assessment plan as needed.

• Is responsible for ensuring that assigned clinical team members comprehend, comply with, and deliver on 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 confirm they accurately represent site management activities and adequately convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS.

• Ensures these deliverables meet company and/or sponsor specifications, including adherence to 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 in accordance with departmental or study agreements.

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

• Demonstrates an understanding of the roles of various functions in achieving compliance and delivery as per protocol, SOPs, ICH GCP, and country regulations.

⛳️ Requirements

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

• Proven ability to lead and align teams towards achieving project milestones.

• Demonstrated capability to work within an international environment.

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

• Preferred experience in risk-based monitoring.

• Understanding of clinical trial management financial principles and budget management.

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

• Must exhibit strong computer skills.

• Excellent conflict resolution abilities.

• Proven capability to apply problem-solving techniques to complex issues and use a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.

• Demonstrates critical thinking to identify the root cause and appropriate solutions for issues.

🏝️ Benefits

• We are dedicated to developing our employees through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and a total rewards program.

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