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eCOA Project Manager
Syneos HealtheCOA Project Manager leading RTSM/eCOA systems design and management for clinical trials at Syneos Health. Collaborates with clinical operations teams to ensure high-quality execution and compliance.
Posted 6/17/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $114,000 - $210,900 per yearWebsite
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
- 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
- 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
- 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 across studies
- Manage RTSM user access requests, modifications, and removals
- Oversee periodic access reviews and audit readiness activities
- Develop and maintain role-based RTSM training materials
- Ensure training aligns with system functionality and regulatory expectations
Requirements
What you’ll need- Bachelor's degree required (BA/BS)
- Minimum of 5 years of operational experience within clinical trials in a pharmaceutical company and/or CRO environment
- Deep expertise in RTSM/IRT (IVRS/IWRS) systems and working knowledge of eCOA platforms
- End-to-end experience managing RTSM system builds, updates, and implementations
- Proven experience leading User Acceptance Testing (UAT) and validation activities
- Hands-on experience working directly with RTSM/eCOA vendors
- Vendor management experience within clinical research environments
- Project management experience supporting complex, matrixed studies or programs
- Strong understanding of the end-to-end clinical trial process
- Familiarity with testing and issue-tracking tools
- Knowledge of GCP principles and applicable regulatory requirements
- Experience supporting inspection readiness activities
- Understanding of SOP compliance and system security controls
Benefits
Comp & perks- Health benefits to include Medical, Dental and Vision
- 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) and sick time
- Company car or car allowance
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
RTSMIRTeCOAUser Acceptance Testingvalidationsystem design documentationUser Requirement Specificationsproject managementclinical trial processGCP principles
Soft Skills
communicationcollaborationleadershipproblem-solvingaccountabilitycontinuous improvementtraining developmentissue escalationvendor managementmatrixed team facilitation
Certifications
Bachelor's degree