Study Implementation Manager coordinating software solution delivery for respiratory studies. Partnering with clients and teams to ensure accurate study configurations and operational excellence.
Responsibilities
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
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