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Syneos Health

eCOA Project Manager

Syneos Health

eCOA 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 & technologies
Google 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

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Applicant Tracking System Keywords

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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