Clinical Trial Manager – Project Management

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

📋 Description

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

• Manages site interactions from activation through to closeout, which may involve patient recruitment, investigator payments, or other associated activities.

• May identify critical data and processes, assess protocol execution risks, and implement risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).

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

• Leverages previous clinical experience, operational data, metrics, and reports to pinpoint risks affecting clinical trial management deliverables.

• Escalates any risks related to clinical trial management deliverables (timeline, quality, and budget) and activities or requests that exceed the contracted scope to the project manager.

• Utilizes strategic thinking and problem-solving abilities to suggest and implement risk mitigation strategies.

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

• Acts as an escalation contact for communications with investigator site staff and may need to interact via phone or in person with principal investigators or other site personnel. This may involve accompanying CRA team members to sites for observation or conflict resolution.

• Works in collaboration with other functional leaders like Study Start Up, Patient Recruitment, and Data Management to synchronize delivery handoffs and achieve expected study milestones such as site activation targets, enrollment goals, and database lock timelines.

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

• Responsible for the creation and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.

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

• Ensures that 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 guidelines, as well as data 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/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 monitor site and patient activities, study team conduct, and ensure data is updated to reflect the timely execution of all operational aspects (required visits/calls, duration, and frequency) as planned.

• Understands the monitoring strategy necessary for the study and, when applicable, participates in developing the study risk assessment plan.

• Is accountable for ensuring that their assigned clinical team members understand, comply with, and deliver according to the established 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 conduct, as well as appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS, ensuring these deliverables adhere to company and/or sponsor specifications, including delivery deadlines.

• Engages with the client 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 for 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 country regulations, including data management, study start up, patient recruitment, medical monitoring, pharmacovigilance, and Quality Assurance (QA).

• Supports Inspection Readiness for the clinical trial management scope.

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

• May develop and assist in executing corrective action plans at the site and study level.

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

• Provides feedback to line managers regarding staff performance, highlighting strengths as well as areas for improvement.

• May be assigned to larger, more complex trials.

⛳️ 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 to achieve project milestones.

• Demonstrated experience working in an international environment.

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

• Preferred experience in risk-based monitoring.

• Demonstrates an understanding of clinical trial management financial principles and budget oversight.

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

• Must exhibit strong computer skills.

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

• Strong conflict resolution capabilities.

• Proven ability to employ problem-solving techniques to address complex issues, applying a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.

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

🏝️ Benefits

• We are dedicated to developing our team through career advancement and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.

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