[Remote] eCOA Project Manager

Note: The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully-integrated life sciences services organization focused on accelerating customer success in drug development. The eCOA Project Manager will lead the operational execution of critical trial systems, ensuring high-quality solutions throughout the study lifecycle while collaborating with cross-functional teams and vendors.

Responsibilities

• 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

Skills

• 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
• Strong analytical and problem-solving capabilities
• Ability to independently identify issues, determine root causes, and implement solutions
• Excellent communication and stakeholder management skills
• Strong organization and prioritization abilities
• Ability to influence cross-functional teams in a matrix environment
• Continuous improvement mindset with a proactive approach to operational excellence

Benefits

• Company car or car allowance
• 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
• Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work
• Syneos complies with all applicable federal, state, and municipal paid sick time requirements

Company Overview

Company H1B Sponsorship