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Home-Based Regional Operations Manager

New Jersey All, NJ

Posted: 02/08/2019 Job Type: Clinical Job Number: JN -022019-23639
  • REMOTE: Candidate must be located in the Northeast, Northern Midwest or Northwest US
  • Experience in Ophthalmology, Dermatology & Device is required
  • Manages Regional Site Managers (RSMs)
  • Ensures appropriate staffing, ascertains that all timelines are met, and upholds quality monitoring standards
  • Functions as a liaison between RSMs and in-house clinical team
  • Manages overall budget compliance for sites
  • Assists in the development and implementation of Global Monitoring Operations policies and represents Global Monitoring Operations in various activities
  • Assign monitors to studies/sites and inform the Clinical Development representative (CDR)
  • Maintain knowledge of study site assignments and manage the workload of individual monitors
  • Interview and hire qualified RSMs to fulfill staffing needs
  • Ensure all department timelines and deliverables are met for the following activities:
    • Monitoring visits, including Pre-Study Site Visits, Site Initiation Visits, Interim Monitoring Visits, and Final Monitoring Visits
    • Monitoring Visit Report (MVR) submission, both electronic and paper versions
    • Freezing of electronic Case Report Forms
    • Retrieval of paper Case Report Forms
    • Completion of FOCAS calendars
    • Submission of expense reports
  • Ensure quality of monitoring activities within the assigned region, by the following:
    • Liaise between the RSMs and in-house clinical team
    • Facilitate flow of information and integrate field team into the in-house clinical study team
    • Conduct regular field evaluation visits with assigned RSMs and provide feedback and direction
    • Review MVRs for accuracy and consistency
    • Provide guidance to RSMs for difficult sites or situations
    • Report significant site issues and associated action plan to GMO management
    • Complete GXP Compliance audit responses in conjunction with RSM and CDR
    • Conduct regular regional teleconferences to provide updates to RSMs, discuss regional issues, and provide guidance
    • Conduct performance appraisals, including regularly providing feedback on job performance and setting goals and objectives for direct reports
    • Provide mentoring and supervision to direct reports, as needed
  • Assist in the development and communication of Global Monitoring Operations policies by the following:
    • Act as a resource for questions about applicable policies
    • Examine opportunities for improvement of procedures and practices
    • Assist in the development of new policies and/or procedures
  • Represent Global Monitoring Operations at Investigators meetings
Requirements:
  • Allied Health Professions degree (PA, RN, RPh) or four-year life science degree
  • 10 years of industry experience
  • Recent/current supervisory experience
  • At least 5 years of previous monitoring experience
  • Both field and in-house experience are desirable
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