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Strategic Data Manager RWD (AI)
Hophr

   Location: New York New York

  Time: 2 weeks ago

 

Essential Functions:

    • Working with data scientists /AIA team leads to collect requirements, consolidate cross-departmental needs and develop processes for their innovative projects leveraging RW
    • Generate guidance on various tracks to help facilitate and execute RWD and novel AIA projects in clinical development space
    • Support contracting, procurement, compliance, statement of work and legal review with the respective experts
    • Working closely with Real-World Data Stewards to implement new processes and move forward projects leveraging RWD
    • Coordinate with legal and compliance to understand what is in scope and out of scope for new projects and how to move them forward; and to comply with regulations
    • Drive forward projects such as: Software as a medical device, Sourcing data from KOLs in a non-interventional study to be used for a CT, Digital twins studies, Hybrid clinical trial designs, Other types of non-interventional clinical studies leveraging both retrospective and prospective data, Projects involving commercial vendors and academic collaborators

Requirements

  •  
    Relevant experience includes:
    • Master’s Degree required with 5+ years of relevant experience; additional relevant advanced degrees my substitute for some experience as deemed appropriate.
    • Experience in pharmaceutical industry (experience within a pharmaceutical or biotech company preferred)
    • Working with legal and compliance in the context of RWD and/or clinical data  
    • Project management across diverse areas of an organization that required change management
    • Education in or 2+ years working as a data scientist highly preferred
    • Working in the digital health space; working knowledge of Software as a medical device (SaMD) highly desired