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Product Owner-Clinical Operations
expires on: November 2, 2020
LOCATION: Minneapolis, MN
JOB #: 101858
JOB TYPE: Consulting
DURATION: Direct Hire
CLIENT: medical device

Your responsibilities will include:

  • Owns the collection of all business requirements for one consolidated, agreed upon list of business requirements
  • Manages the product backlog and utilizes agreed prioritization approach to develop long-term activity roadmaps
  • Oversees the development of the product; understands and anticipates divisional needs to effectively manage the development process
  • Primary communication and link between GCO, divisions and stakeholders
  • Engages with regional teams to understand their business requirements and ensures they are included in implementation strategies for expanded functionality
  • Responsible for the final product of the development process; includes inspecting and evaluating product progress through each phase

Legacy Systems

  • Define sunset strategy and timeline for acquired EDC systems once integrations are complete.

EDC System

  • Works in collaboration with the CTMS/eTMF and Keystone Product Owners to gather requirements for electronic data capture migration and integration strategy by division, as appropriate
  • Obtain, consolidate, prioritize business requirements gathering across all divisions
  • Partnering with Corporate Communications Group on Change Management strategies
  • Partner with Corporate IT on evaluating business requests and implementation plans
  • Develop business side UAT plans and necessary resources
  • Coordinate with GCO and Divisional colleagues in developing implementation phases
  • Owner of data flow 2 (spaghetti map) Veeva Vault (In’s and Out’s) – Framework from IT
  • Develop data cleanup plans with IT (as appropriate to support other technology pillars)

Minimum Qualifications

  • Bachelor’s degree in a related field
  • Experience planning and managing technology business requirements
  • 5+ years of experience in project or program management
  • 3+ years’ direct experience working with EDC clinical software solutions in clinical operations (e.g. Medidata Rave)
  • Experience managing communication with diverse stakeholders to ensure delivery to a high degree of satisfaction

Preferred Qualifications

  • Effective communication skills, both verbal and written, across multiple levels of an organization
  • Understands clinical research process and regulatory requirements
  • Demonstrated experience working on products in accordance with FDA compliance and regulatory requirements
  • Experience gathering requirements and launching new systems
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