Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The eCOA Project Manager is responsible for the end-to-end planning, implementation, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions across assigned clinical trials, ensuring delivery aligns with study requirements and regulatory standards.
Responsibilities:
- The eCOA Manager is responsible for the end‑to‑end planning, implementation, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions across assigned clinical trials. This role acts as the primary point of accountability for eCOA delivery, ensuring systems are configured, validated, deployed, and maintained in alignment with study requirements, regulatory standards, and sponsor expectations
- The eCOA Manager partners closely with Clinical Operations, Data Management, Biostatistics, vendors, and sponsors to deliver high‑quality, patient‑centric electronic assessment solutions that support protocol objectives, data integrity, and study timelines
- Lead eCOA delivery activities from startup through clos-out, including requirements gathering, system build, UAT script writing, UAT conduct, ongoing maintenance, etc
- Develop and manage eCOA project plans, timelines, and risk mitigation strategies in alignment with study milestones
- Serve as primary eCOA subject matter expert for assigned studies, providing guidance, implementing lessons learned and best practices
- Main liaison with eCOA vendor overseeing deliverables, issue resolution, timelines, etc
- Collaborate with internal stakeholders (i.e., clinical, DM, biostats, etc.) and sponsor
- Lead/support sponsor communications, participation in governance meetings and provision of status updates through the life of the study
- Oversee eCOA system build, including questionnaires (also knows as scales, assessments or instruments), visit schedules, languages, devices, etc
Requirements:
- Subject matter expertise in eCOA technologies and patient‑reported outcomes
- Strong project and vendor management skills
- Excellent communication and stakeholder engagement abilities
- High attention to detail with a quality‑focused mindset
- Ability to proactively identify risks and drive solutions