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Patient Reported Outcomes Manager

Spectraforce Technologies Inc

Job Title: Patient Reported Outcomes Manager Assignment Duration: 1 Year Location: North Chicago IL Job 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. Key Points 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 Key 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 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 Preferred Experience 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 #J-18808-Ljbffr

Vacancy posted 1 day ago
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