eCOA Project Manager – North America, Argentina

This is a fully remote position, open to applicants in United States, +3 more countries.

📋 Description

• Oversee eCOA initiatives from the beginning of the study to its conclusion.

• Manage project-specific eCOA plans, timelines, milestones, and deliverables.

• Act as the primary eCOA subject matter expert for designated clinical studies.

• Ensure that electronic assessments conform to protocol requirements, study goals, and regulatory standards.

• Support global studies that involve patient-reported outcomes, clinician-reported outcomes, as well as other electronic assessments.

• Facilitate the application of lessons learned and best practices for continuous improvement.

• Supervise the design, configuration, and deployment of eCOA software.

• Manage questionnaires, instruments, scales, assessments, visit schedules, device settings, language requirements, and study workflows.

• Ensure that systems are accurately built, validated, and maintained.

• Review and approve deliverables from vendors.

• Coordinate updates, enhancements, and maintenance of systems.

• Develop strategies for User Acceptance Testing (UAT) and test scripts.

• Lead and carry out UAT activities.

• Identify, document, and resolve any testing issues.

• Drive the creation of inspection-ready documentation and testing records.

• Serve as a liaison among sponsors, internal teams, and eCOA vendors.

• Manage vendor timelines, deliverables, risks, and issue resolutions.

• Provide updates on project status and communicate key milestones.

• Participate in governance meetings and discussions with sponsors.

• Proactively escalate risks and implement solutions.

• Collaborate with Clinical Operations, Data Management, Biostatistics, Clinical Science, Assessment Science, Project Management, Technology Vendors, and Sponsors.

• Assist study teams in eCOA processes, timelines, and best practices.

• Oversee assessment licensing and procurement of copyrights.

• Coordinate with copyright holders and key opinion leaders.

• Manage the translation of scales and instruments.

• Partner with translation vendors.

• Oversee translation timelines, documentation, and vendor deliverables.

• Identify project risks and develop strategies to mitigate them.

• Monitor the health of studies, timelines, and quality metrics.

• Ensure adherence to SOPs, work instructions, sponsor requirements, and industry regulations.

• Maintain project documentation and assist in Trial Master File (TMF) readiness.

• Support audits, inspections, and quality initiatives.

• Manage competing priorities across various studies.

• Offer guidance and mentorship to project specialists and team members.

• Assist in resource planning and forecasting.

• Contribute to initiatives aimed at process improvement.

• Act as a trusted consultant and problem solver for eCOA-related challenges.

⛳️ Requirements

• Bachelor's degree or an equivalent combination of education and relevant experience.

• A minimum of 4+ years of project management experience in eCOA, eClinical technologies, clinical trial technology vendors, CRO environments, or pharmaceutical or biotechnology organizations.

• Proven experience in leading comprehensive eCOA implementations across clinical studies.

• Experience in managing software implementation projects and complex vendor relationships.

• Experience in authoring and executing User Acceptance Testing (UAT) plans and scripts.

• Experience collaborating with cross-functional clinical research teams.

• Strong understanding of eCOA platforms and technologies.

• Solid understanding of patient-reported outcomes (PROs).

• Strong knowledge of clinical trial operations.

• Strong familiarity with clinical study protocols.

• Strong grasp of data quality principles.

• Strong understanding of vendor oversight and governance.

• Strong knowledge of risk management methodologies.

• Exceptional organizational, communication, and stakeholder management abilities.

• Demonstrated capability to manage multiple studies and competing priorities simultaneously.

• Strong attention to detail coupled with a quality-focused mindset.

• Ability to proactively identify problems and implement effective solutions.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a total rewards program.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company match for 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO).

• Sick leave benefits.

• Reasonable accommodations provided when appropriate.