Covance

  • Mgr Clin Ops II - Medical Device

    Job Location(s) US-Nationwide
    Job Number
    2018-20747
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Clinical Operations Manager - Medical Device

    Manager, Clinical Operations - Medical Device

    GCP and Quality Oversight:

    ¨      Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented

    ¨      Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Quality Control Visits

    ¨      Ensures training record compliance with training matrix and ensures training records are up to date

    ¨      Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff

    ¨      Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins

    ¨      Hold Clinical Operations and CoSource staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate

    • Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
    • Hold CoSource staff accountable for quality and compliance with client SOPs and adherence to Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverablesProductivity and Financial Management:¨      Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation¨      Adheres to global tools for monitoring and utilization forecasting¨      Assist with staff recruitment through screening and interviewing¨      Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports¨      Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
    • ¨      Schedule Quality Control Visits to ensure costs are in alignment with regional budget
    • ¨      Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma
    • ¨      Financial authority in accordance with current signature approval matrix
    • ¨      Engage in Resource management activities for direct reports
    • ¨      Escalates available workload hours, in context of project allocation, supply and demand, to management team
    • ¨      Communicate status of assigned workload for metric reporting
    • ¨      Coach assigned staff to own effective Investigator relations and Investigator oversight at the local level

    Education/Qualifications

    Required:

    • University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
    • In lieu of this required educational background the following relevant work history may be considered:
      • Minimum of three (3) years supervisory experience in a health care or clinical research setting and
      • Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO
      •  
      • Preferred:
    • Masters or other advanced degree

    Experience

    • Relevant clinical research experience in a pharmaceutical company or CRO
      • Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
      • Minimum of five (5) years relevant clinical research experience in a pharmaceutical company/CRO
      • Thorough knowledge of drug development process
      • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines
    • Relevant supervisory experience
      • Minimum of 1 year as a Line Manager or Project Manager required
      • Demonstrated ability to lead by example and to encourage team members to seek solutions
      • Proven interpersonal skills
      • Demonstrated ability to successfully participate as a member of a project team
      • Demonstrated ability to successfully manage multiple competing priorities
      • Advanced planning and organizational skills
      • Advanced oral, written and presentation skills
      •  

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