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Director of Registry and Biorepository - Research - REMOTE

Company: Michael Page
Location: New York
Posted on: November 22, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryPerform tasks necessary to coordinate diverse activities and enable the start of patient registry. Help identify the most appropriate vendors for providing the specialized components for the registry database. Client DetailsOur client is a leading non-governmental, non-profit funder of Lupus research. This company has invested hundreds of millions of dollars in Lupus research. This includes over 500 research and clinical studies. They are responsible for the coordination, conduct and management of North American-based clinical trial network. Currently, they have multiple studies in Phase 1 - Phase III of clinical trials. Description

  • Manage collaborations between academic investigators, industry partners and the patient community to create the first lupus platform coalescing clinical samples/data, analytics and collaborations to accelerate lupus research and development
  • Coordinate the activities of the individual Working Groups informing the build of the department
  • Ensure accurate, timely and thorough communication between the Steering Committee and the Working Groups
  • Oversee the selection of the information technology platform components and manage its implementation and maintenance along with a technology consultant
  • Manage the vendor selection process from solicitations (preparation of RFPs) to evaluations (reviews of proposals) and contracts execution
  • Work with staff and investigators to coordinate the planning of a prospective, longitudinal clinical study that will frame the registry component of the group
  • Manage the business and financial planning for the group, including oversight of the budget
  • Establish and oversee partnerships with diagnostic/genomic/other companies that support the goals and objectives
  • Collaborate with staff to ensure timely execution of all contracts (site contracts, Material and Data Transfer Agreements, etc.) and IRB/EC approvals
  • Collaborate with staff to assist the clinical study operations specifically with the development/refinement of the clinical trial protocol and associated informed consent documents, preparation/execution of protocol-specific training materials and data collection tool training materials and with the conduct of site training
  • Collaborate with staff and oversee the group staff to assist in clinical study monitoring and site management/monitoring efforts
  • Manage existing group consultants and hiring/management of future staff in line with the operational requirements of the business planProfile
    • BS degree or higher with educational training in a field related to the health sciences
    • 8+ years of life science experience in operations or clinical trial settings
    • 5+ years of experience coordinating multicenter studies that involve clinical/phenotypic data and biosamples collection ideally in a biotech or pharmaceutical setting (biorepository-related project coordination preferred)
    • Understanding of Electronic Health Record systems. Experience working with Epic and extracting data from Epic as well as knowledge of REDCap and/or related platforms preferred
    • Working knowledge of GCP/ICH/CLIA guidelines and FDA regulations
    • Proficiency in cross-functional collaboration with varied teams and stakeholders
    • Prior exposure to software development processes to create tools for sample/data management preferred
    • Certificate of training for Human Subjects Research preferred
    • Ability to travel is required
    • Demonstrated ability to think strategically when planning and managing responsibilities
    • Hands-on, self-directed, detail-oriented, organized, and conscientious
    • Must work independently and prioritize and manage multiple projects within tight timelines
    • Team player who can build excellent working relationships both internally and externally.Job Offer
      • Competitive base salary
      • Industry best Heatlh Benefits
      • Standard PTO policy
      • Fully REMOTE work availableJob Requirements:BS degree or higher with educational training in a field related to the health sciences 8+ years of life science experience in operations or clinical trial settings

Keywords: Michael Page, New York , Director of Registry and Biorepository - Research - REMOTE, Executive , New York, New York

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