eCOA Project Manager

Responsibilities

• End-to-End RTSM/eCOA Leadership
• Lead the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems.
• Partner closely with Clinical Operations and study teams to understand protocol requirements and ensure alignment on timelines, scope, and deliverables.
• Develop and maintain User Requirement Specifications (URS) and system design documentation.
• Serve as the primary operational point of contact for RTSM activities across assigned studies.
• Provide ongoing RTSM/eCOA expertise throughout the entire study lifecycle.
• System Delivery, Testing & Validation
• Lead User Acceptance Testing (UAT) activities and validation efforts.
• Ensure completion, review, and filing of testing and validation documentation.
• Oversee quality reviews and approval of validation documentation.
• Collaborate with vendors and study teams to identify, investigate, and resolve system issues.
• Manage emergency changes and change control activities.
• Vendor & Stakeholder Management
• Act as the liaison between Clinical Operations, RTSM/eCOA vendors, and internal stakeholders.
• Drive accountability for vendor deliverables and timelines.
• Facilitate effective communication across matrixed teams.
• Support issue escalation and resolution activities.
• Process Excellence & Inspection Readiness
• Ensure RTSM processes align with SOPs, regulatory requirements, and quality standards.
• Support inspection readiness initiatives.
• Identify process gaps and implement continuous improvement opportunities.
• Develop standardized RTSM workflows and supporting guidance documents.
• Ensure consistent execution ac

Benefits

Additional Information

eCOA Project Manager Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities eCOA Project Manager Sponsor-Dedicated | Remote (U.S. & Canada) Are you an RTSM expert who thrives in complex clinical environments and enjoys owning the operational execution behind critical trial systems? This is a highly visible opportunity supporting a diverse portfolio of clinical trials where RTSM, IRT, and eCOA systems play a critical role in study execution. The ideal candidate is someone who combines deep technical expertise with strong project management capabilities and enjoys partnering cross-functionally to deliver high-quality solutions throughout the entire study lifecycle. You won't simply oversee vendors from a distance-you'll serve as the operational lead and subject matter expert, ensuring that systems are designed, tested, implemented, and maintained to the highest standards of quality and compliance. If you enjoy solving complex problems, driving continuous improvement, and collaborating across functions to support successful clinical trials, this could be an excellent next step in your career. WHY THIS OPPORTUNITY High-impact role supporting multiple studies across a diverse clinical portfolio. Opportunity to serve as the RTSM/eCOA Subject Matter Expert within a sponsor-dedicated environment. Significant ownership and visibility across Clinical Operations and cross-functional teams. Strong partnership with vendors and internal stakeholders. Fast-paced environment where innovation and problem-solving are valued. Opportunity to influence and standardize RTSM processes and best practices. Collaborative culture focused on quality, accountability, and continuous improvement.

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