ECOA Project Manager

Job 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 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.

• 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.
• 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.

• United States
• Canada

The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, company match 401(k), eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

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The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.