Study Implementation Manager

Role Overview

• Coordinate the full software solution delivery process for respiratory studies, ensuring implementations meet requirements and remain within scope
• Serve as a subject matter expert (SME) for the Expert platform and study‑level configuration
• Communicate and collaborate with prospects and clients regarding product capabilities, configuration options, and use cases to ensure accurate Project Requirement Specifications (PRS)
• Review, analyze, and consult with internal Project Managers and clients on protocol requirements to determine technical implementation needs
• Create and maintain detailed specifications for study implementations across all assigned projects
• Develop and maintain client‑specific Expert templates
• Set up study‑specific devices and perform initial smoke testing prior to V&V handoff
• Support Project Managers during client UAT activities, including test script review and software walkthroughs
• Present and explain the PRS during client kick‑offs and throughout the study lifecycle, including for amendments
• Track and communicate configuration status, timelines, scope changes, and data‑related impacts both internally and externally
• Participate in client meetings (kick‑off, UAT, status) and provide technical and configuration guidance as needed
• Serve as a liaison with Technical Support and cross‑functional teams to investigate and resolve technical usage issues
• Support project scope and change‑control processes, including revision management
• Provide critical inputs across Sales‑to‑Service, Kick‑Off, Solutions Overview, Specification Review, and Software Review stages
• Coordinate with Quality Assurance, Software Development, and other internal groups to ensure accurate understanding and execution of study requirements
• Contribute to continuous improvement activities, workflow enhancements, documentation updates, and trainings related to new devices or Expert enhancements

Requirements

• Bachelor’s degree in MIS, Computer Science, Technical Communication, Research Methodology, Psychology, or a related field
• Minimum 5 years of experience supporting or executing clinical research studies (pharmaceutical/biotech preferred)
• Strong client relationship management skills with excellent written, verbal, and visual communication abilities
• Experience creating clear and usable documentation; technical writing experience is a plus
• Proficiency with technology, technical/clinical terminology, and web‑based systems
• Experience in a technical, operational, or project management role
• Demonstrated ability to coordinate tasks, manage timelines, and deliver on project goals
• Strong organizational, time‑management, and problem‑solving skills
• Ability to work independently in a fast‑paced, dynamic environment with minimal supervision
• Proficiency with Microsoft Word, Excel, PowerPoint, and Visio; experience with remote presentation tools (e.g., WebEx)
• Ability to collaborate effectively with global, remote teams
• Ability to travel approximately 20–30% based on client needs

Benefits

• Competitive compensation
• Medical, dental, and vision coverage
• Flexible and paid time off
• Remote and hybrid work options
• Tuition reimbursement
• Employee assistance and wellness programs
• Life and disability insurance