Patient Data Manager
Randstad Life Sciences US - north chicago, IL
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Patient Experience Data & Strategy Manager1 YearREMOTEPurpose:The Manager, Patient Experience Data & Strategy role within the Patient-Centered Outcomes Research (PCOR) team works independently while under the supervision of a Director to design and execute patient experience data (PED) evidence research to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial). HeShe develops research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple products indications. This research includes literature and landscape reviews, the development and validation of Clinical Outcome Assessments (COAs), and analyses of COA endpoints. In addition, heshe supports integration of COA measurement strategies into clinical development programs and develops high-quality documentation to summarize PED for communication in regulatory submissions. HeShe presents research findings internally to stakeholders within Company and externally. In addition, the Manager builds research relationships with key external thought leaders, fostering industry research collaboration. The employee must conduct their work activities in compliance with all Company internal requirements and with all applicable regulatory requirements.Responsibilities:Conducts literature & landscape reviews to identify concepts of importance to patients to develop disease conceptual modelsIdentifies & evaluates existing COA tools to determine the extent to which the assessments are fit-for-purposeLeads development & integration of COA measurement strategy into clinical development programs through clinical trial program support (e.g., protocolSAP content development, results interpretation and CSR development) and ensures appropriate implementation of COAs on eCOA platforms in global programsLeads design and execution of qualitative research, psychometric analyses, and development of new COA toolsContributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpointsDevelops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical methodological congressesContributes to development of PED standardsbest practices and educational resources for functions across Company to drive the integration of patient voice in development programsDevelops and manages publication creation, review approval, submission and presentation of research in peer-reviewed journals and at medical methodological congresses.Qualifications:Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferredProfessional experience and training preferred (minimum 2 years of research experience required. Work experience can include fellowship experience)Firm understanding of the scientific fundamentals of COA research & measurement scienceAbility to work collaborativelyStrong interpersonal skills with an ability to leverage expertise to understand, respond effectively across stakeholdersDemonstrated ability to manage multiple projects involving complex processes, significant budget, competing deadlines and rapidly shifting prioritiesStrong written and verbal communication skillsExperience in handling delivery of services across complex environmentsExperience in managing projects from design through executionSome experience knowledge of the pharmaceutical industry (knowledge of regulatorycompliance frameworks) and clinical trial designDemonstrated initiative and strong work ethicWillingness to travel as required
Created: 2024-10-19