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Over 80 of the Fortune 100, 10,000 large enterprises, and millions of smaller organizations trust Proofpoint to stop threats, prevd Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.Reviews the 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 to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
Is accountable 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 pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.Document requested revisions and approvals in CTMS.




Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.Provides solutions for obstacles in protocol execution and site management.
Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
Supports Inspection Readiness for clinical trial management scope.
Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
May develop and support execution of corrective action plans at site and study level.Supports and completes activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance including strengths as well as areas for development.
May be assigned to larger,more complex trials.QualificationsBachelor's degree or RN in a related field or equivalent combination of education,



training and experienceDemonstrated ability to lead and align teams in the achievement of project milestonesDemonstrated capability of working in an international environmentDemonstrated expertise in site management and monitoring (clinical or central)Preferred experience with risk-based monitoringDemonstrates understanding of clinical trial management financial principles and budget managementKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsMust demonstrate good computer skillsGood communication, presentation and interpersonal skills among project team and with sitesStrong conflict resolution skillsDemonstrated 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 projectDemonstrates critical thinking to determine the cause and appropriate solution in the identification of issuesModerate travel may be required, approximately 20%Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief terms.
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, in relation to the recruitment and employment of its employees.
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.
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📌 Software Engineer Iii, Applied Agentic Ai (Mendoza)
🏢 7257 Syneos Health Argentina
📍 Mendoza