Clinical Trial Manager – Project Management, CRA

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

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables, emphasizing patient safety, protocol/GCP/compliance, and data integrity.

• Manages site interactions from activation through to closeout.

• May identify critical data and processes, along with protocol execution risks and mitigation strategies related to the completion of the Risk Assessment and Categorization Tool (RACT).

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

• Leverages prior clinical experience, operational data, metrics, and reports to identify risks associated with clinical trial management deliverables.

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

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

• Participates in and presents at key meetings, including 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 via phone or in person.

• This may involve 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 expected 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) in relation 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 configured and accessible for the clinical team's use, 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, guidelines, and study timelines.

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

• Maintains the quality of clinical monitoring, central monitoring, and site management deliverables within a project and ensures proper visibility of progress using 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 oversee site and patient activities, study team conduct, and ensure that data is updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to the plan.

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

• Is responsible 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 ensure they accurately represent site management activities and convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS.

• Ensures these deliverables are provided according to company and/or sponsor specifications, including deadlines.

• Engages with the client and other functional departments concerning clinical monitoring, central monitoring, and site management activities and deliverables.

• Provides status updates regarding 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 other functions in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.

• This may encompass data management, study start-up, patient recruitment, medical monitoring, pharmacovigilance, and Quality Assurance (QA).

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

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

• May develop and assist in executing corrective action plans at both site and study levels.

• Aids in completing activities to meet data cut and lock deadlines.

• Provides performance feedback to line managers, 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 toward achieving project milestones.

• Demonstrated capability to operate in an international environment.

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

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

• Strong conflict resolution abilities.

• Demonstrated capability to apply problem-solving techniques to address complex issues and utilize a risk management approach to identify and mitigate potential threats to the successful execution of clinical research projects.

• Exhibits critical thinking to determine the root cause and appropriate solutions in issue identification.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• We are dedicated to nurturing our employees' growth through career development and advancement opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and comprehensive rewards program.

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

• Driven to Deliver, reflecting the passion of our colleagues to show up every day and create solutions that can significantly impact lives.