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Patient Reported Outcomes Manager

Job Title: Patient Reported Outcomes ManagerAssignment Duration: 1 YearLocation: Remote or Hybrid, preference for local candidatesJob Summary: 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-heavyStrong project management and clinical trial experience take priority over direct PRO experienceStrong clinical trial experience with project management is more important than direct PRO experienceExposure or training in PRO/ePRO licensing is acceptable without direct ownershipCandidates should have stable career trajectories and relevant background; overqualified candidates (~15+ years) may not be a fitPhD candidates are generally not preferred for this roleKey Responsibilities: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.Qualifications & Requirements:Education & Experience: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 preferredSkills & Competencies:Strong project management skills, including managing timelines, stakeholders, and deliverablesKnowledge or experience with Patient Reported Outcomes (PRO/ePRO) is preferred but not mandatoryUnderstanding of PRO licensing, permissions, or translation processes is a plusCompetent in standard operating procedures (SOPs) and Good Clinical Practices (GCP)Strong organizational, documentation, and analytical skillsAbility to work with systems such as Veeva Vault and tracking tools like SmartSheetExcellent communication skills and ability to coordinate cross-functionallyAbility to translate tracking data into actionable updates and insightsDemonstrated ability to build relationships across teams and geographic locationsFlexible, fast learner, and open to process improvementsPreferred Experience:Roles such as Clinical Research Coordinator, CRA/Monitor, Regulatory Coordinator, or similarExposure to licensing or translation processes within clinical trialsSpecialized CDIT/PRO experience may allow consideration with slightly fewer years of experienceTypical Day/Week Activities:Manage receipt and tracking of PRO questionnairesUpload and maintain documents in VaultCoordinate translation workflows and training requirementsEnsure tracking tools are up-to-dateSupport study start-up activities and ensure documentation completeness before handoffMonitor operational deliverables and timelines

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