ePRO and eClinRO Licensing

The Patient Reported Outcomes Management Associate III will drive and manage deliverables across the PRO/ePRO process, from licensing to implementation, ensuring timelines are met and potential trial-specific efficiencies are identified. This role serves as the central point of contact for therapeutic areas within Clinical Program Development (CPD) and provides expertise in PRO/ePRO activities during study start-up.

• This is a highly operational and execution-focused role, not strategy-heavy
• Strong project management and clinical trial experience take priority over direct PRO experience
• Strong clinical trial experience with project management is more important than direct PRO experience
• Exposure or training in PRO/ePRO licensing is acceptable without direct ownership
• Candidates should have stable career trajectories and relevant background; overqualified candidates (~15+ years) may not be a fit
• PhD candidates are generally not preferred for this role, * Provide expertise and consultation on patient-centered PRO licensing and translation activities across all therapeutic areas within CPD.
• Maintain the Vault PRO Library, including licensing, permissions, MSAs, translation requirements, training requirements, and electronic format specifications.
• Collaborate with PRO owners, outsourcing partners, HEOR, Data Sciences, and clinical teams to facilitate PRO/ePRO implementation.
• Manage vendor contract initiation, translation workflows, project milestones, timelines, and deliverables.
• Provide strategic and technical guidance and training to CPD teams in PRO/ePRO processes.
• Oversee study start-up activities, including receipt/tracking of questionnaires, document uploads in Vault, translation coordination, and finalization of study binders.
• Maintain tracking tools (SmartSheet or equivalent) to monitor progress, timelines, and deliverables.
• Focus on operational excellence, process adherence, and cross-functional coordination., * Roles such as Clinical Research Coordinator, CRA/Monitor, Regulatory Coordinator, or similar
• Exposure to licensing or translation processes within clinical trials
• Specialized CDIT/PRO experience may allow consideration with slightly fewer years of experience

Typical Day/Week Activities:

• Manage receipt and tracking of PRO questionnaires
• Upload and maintain documents in Vault
• Coordinate translation workflows and training requirements
• Ensure tracking tools are up-to-date
• Support study start-up activities and ensure documentation completeness before handoff
• Monitor operational deliverables and timelines

• Bachelor's degree in a scientific field (Associate degree with relevant experience may be considered)
• Minimum 4 years of global clinical research or project management experience (direct or peripheral)
• Experience in clinical trials is critical; exposure to end-to-end processes (e.g., coordinator, monitor, regulatory) is preferred

Skills & Competencies:

• Strong project management skills, including managing timelines, stakeholders, and deliverables
• Knowledge or experience with Patient Reported Outcomes (PRO/ePRO) is preferred but not mandatory
• Understanding of PRO licensing, permissions, or translation processes is a plus
• Competent in standard operating procedures (SOPs) and Good Clinical Practices (GCP)
• Strong organizational, documentation, and analytical skills
• Ability to work with systems such as Veeva Vault and tracking tools like SmartSheet
• Excellent communication skills and ability to coordinate cross-functionally
• Ability to translate tracking data into actionable updates and insights
• Demonstrated ability to build relationships across teams and geographic locations
• Flexible, fast learner, and open to process improvements