eCOA Project Manager with at least 2 years of experience in Clinical Trials & eCOA technologies - Argentina Home Based

📋 Description

• • Lead end-to-end planning, implementation, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions across assigned clinical trials, ensuring alignment with study requirements, regulatory standards, and sponsor expectations.
• • Serve as the primary point of accountability for eCOA delivery, managing all phases from startup through study close-out, including requirements gathering, system configuration, UAT script development, UAT execution, and ongoing maintenance.
• • Develop and manage detailed eCOA project plans, timelines, and risk mitigation strategies that align with key study milestones and deliverables.
• • Act as the main liaison between internal teams (Clinical Operations, Data Management, Biostatistics) and external eCOA vendors, overseeing vendor deliverables, issue resolution, and timeline adherence.
• • Configure eCOA systems including questionnaires (scales, assessments, instruments), visit schedules, language translations, and device specifications to meet protocol-specific needs.
• • Collaborate with internal stakeholders and sponsors to ensure eCOA solutions support protocol objectives, data integrity, and patient-centric design.
• • Lead and support sponsor communications, including participation in governance meetings and providing regular status updates throughout the study lifecycle.
• • Serve as the subject matter expert for eCOA technologies and patient-reported outcomes, implementing best practices and lessons learned across projects.
• • Proactively identify potential risks in eCOA deployment and drive timely, effective solutions to maintain study timelines and data quality.
• • Ensure all eCOA activities comply with applicable regulatory standards and sponsor quality expectations, maintaining a high attention to detail and quality-focused mindset.
• • Partner with cross-functional teams to optimize patient experience through intuitive, reliable, and accessible electronic assessment tools.
• • Maintain comprehensive documentation of eCOA configurations, changes, and validation activities to support audit readiness and regulatory compliance.
• • Apply deep knowledge of eCOA platforms and patient-reported outcome (PRO) methodologies to enhance data collection efficiency and clinical trial outcomes.
• • Contribute to continuous improvement by identifying opportunities to streamline eCOA processes and share knowledge across the Clinical Solutions team.
• • Support the adoption of innovative eCOA technologies and methodologies to improve trial efficiency and patient engagement.