eCOA Project Manager – North America, Argentina

🔥 0 minutes ago

🌐 United States, Canada, +2 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote

💵 $79.8k - $139.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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 • Oversee eCOA software design, configuration, and deployment • Manage questionnaires, instruments, scales, assessments, visit schedules, device configurations, language requirements, and study workflows • Ensure systems are built, validated, and maintained accurately • Review and approve vendor deliverables • Coordinate system updates, enhancements, and maintenance • Develop UAT strategies and test scripts • Lead and execute UAT activities • Identify, document, and resolve testing issues • Drive inspection-ready documentation and testing records • Liaise between sponsors, internal teams, and eCOA vendors • Manage vendor timelines, deliverables, risks, and issue resolution • Provide project status updates and communicate key milestones • Participate in governance meetings and sponsor-facing discussions • Escalate risks proactively and drive solutions • Collaborate with Clinical Operations, Data Management, Biostatistics, Clinical Science, Assessment Science, Project Management, Technology Vendors, and Sponsors • Support study teams with eCOA processes, timelines, and best practices • Manage assessment licensing and copyright procurement • Coordinate with copyright holders and key opinion leaders • Oversee scale and instrument translations • Partner with translation vendors • Manage translation 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 project documentation and contribute to Trial Master File (TMF) readiness • Support audits, inspections, and quality initiatives • Manage competing priorities across multiple studies • Provide guidance and mentorship to project specialists and team members • Support resource planning and forecasting • Contribute to process improvement initiatives • 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, or 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 • Strong understanding of patient-reported outcomes (PROs) • Strong understanding of clinical trial operations • Strong understanding of clinical study protocols • Strong understanding of data quality principles • Strong understanding of vendor oversight and governance • Strong understanding of 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

🏖️ Benefits

• career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations, when appropriate