eCOA Project Manage- Remote/North America (US, Canada, Mexico) & Argentina

Syneos Health is a fully integrated life sciences services organization that supports drug development and commercialization. The eCOA Project Manager will lead the end-to-end delivery of electronic Clinical Outcome Assessment solutions across global clinical trials, overseeing implementation, system builds, testing, vendors, stakeholders, quality, and study timelines.

Responsibilities:

• Lead eCOA activities from study startup through closeout
• Manage study-specific eCOA project plans, timelines, milestones, and deliverables
• Serve as the primary eCOA subject matter expert for assigned clinical studies
• Ensure electronic assessments align with protocol requirements, study objectives, and regulatory expectations
• Support global studies involving patient-reported outcomes, clinician-reported outcomes, and other electronic assessments
• Drive implementation of lessons learned and continuous improvement best practices across programs
• Oversee study-specific eCOA software design, configuration, and deployment
• Manage eCOA system builds, including:
• Questionnaires and instruments
• Scales and assessments
• Visit schedules
• Device configurations
• Language requirements
• Study workflows
• Ensure systems are built, validated, and maintained with a high degree of accuracy
• Review and approve vendor deliverables throughout the build lifecycle
• Coordinate system updates, enhancements, and ongoing maintenance activities
• Develop comprehensive User Acceptance Testing (UAT) strategies and test scripts
• Lead and execute UAT activities to validate study functionality
• Identify, document, and resolve testing issues in collaboration with vendors and stakeholders
• Ensure all eCOA solutions meet quality expectations before deployment
• Drive inspection-ready documentation and testing records
• Serve as the primary liaison between sponsors, internal teams, and eCOA vendors
• Manage vendor timelines, deliverables, risks, and issue resolution
• Build strong relationships with sponsors and cross-functional study teams
• Provide regular project status updates and communicate key milestones
• Participate in governance meetings and sponsor-facing discussions
• Escalate risks proactively and drive solutions to keep projects on track
• Partner closely with:
• Clinical Operations
• Data Management
• Biostatistics
• Clinical Science
• Assessment Science
• Project Management
• Technology Vendors
• Sponsors
• Ensure alignment across all stakeholders throughout study execution
• Contribute to broader project plans to support successful study delivery
• Support study teams in understanding eCOA processes, timelines, and best practices
• Manage assessment licensing and copyright procurement activities
• Coordinate with copyright holders and key opinion leaders as required
• Oversee scale and instrument translations supporting global clinical trials
• Partner with translation vendors to ensure high-quality multilingual implementations
• Manage associated timelines, documentation, and vendor deliverables
• Identify project risks and develop mitigation strategies
• Monitor study health, timelines, and quality metrics
• Ensure compliance with SOPs, work instructions, sponsor requirements, and industry regulations
• Maintain ongoing project documentation and contribute to Trial Master File (TMF) readiness
• Support internal audits, sponsor audits, inspections, and quality initiatives
• Manage competing priorities across multiple studies simultaneously
• Provide guidance and mentorship to project specialists and team members
• Support resource planning and forecasting activities
• Contribute to process improvement initiatives that enhance quality, efficiency, and customer experience
• Serve as a trusted consultant and problem solver for eCOA-related challenges

Requirements:

• Bachelor's degree or equivalent combination of education and relevant experience
• Minimum of 4+ years of project management experience within:
• eCOA
• eClinical technologies
• Clinical trial technology vendors
• CRO environments
• Pharmaceutical or biotechnology organizations
• Demonstrated experience leading end-to-end eCOA implementations across clinical studies
• Experience managing software implementation projects and complex vendor relationships
• Experience 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
• Patient-reported outcomes (PROs)
• Clinical trial operations
• Clinical study protocols
• Data quality principles
• Vendor oversight and governance
• Risk management methodologies
• Exceptional organizational, communication, and stakeholder management skills
• Demonstrated ability to manage multiple studies and competing priorities simultaneously
• Strong attention to detail with a quality-focused mindset
• Ability to proactively identify problems and implement effective solutions
• Experience supporting global clinical trials
• Experience managing multilingual eCOA deployments and translation activities
• Experience with assessment licensing and copyright management
• Experience supporting sponsor-facing governance meetings
• Exposure to Clinical Outcome Assessments (COAs), PROs, ClinROs, ObsROs, or PerfOs
• Background working in clinical technology, digital health, or patient-engagement platforms
• Experience mentoring junior project team members
• Psychology, behavioral science, or assessment-related experience is a plus