Clinical Study Manager

Company: ProKatchers ( Learn More )

General Information
Not Specified
At least 5 year(s)
Not Specified
Job Description

Job Title: Clinical Study Manager
Location: Northbrook, IL
Duration: 2+ years
Client: Pharmaceutical

Purpose and Scope of Position:

  • Plan, initiate and execute clinical studies (may have more than 1 and may be global) and implement appropriate standards and processes to ensure clinical study quality.
  • Responsible for effective management of budgets, timelines and resources for assigned clinical studies
  • Participate in task force or initiatives representing CSM
  • The scope of this position is Phase 1 through 4 clinical studies

  • Essential Job Responsibilities

  • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Manage and lead cross-functional study teams, including vendors.
  • Responsible for accurate and up-to-date study information within CTMS and other relevant tracking systems and providing regular updates; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
  • Lead development of budgets and timelines for assigned studies. Ensure accurate forecasting, tracking, timely review and escalation of variances within established processes.
  • Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team documents
  • Be accountable for effective training of study team, study sites and vendors for assigned clinical studiesĀ 
  • Job RequirementsICH

    Education & Qualification

    • Minimum BA/BS degree or RN with 5+ years of direct clinical study management/project management experience including managing onoclogy trials of which 3 years must be direct study management in the pharmaceutical industry, including all stages of study conduct (start-up, maintenance, close-out).
    • Global study experience is HIGHLY desired.
    • Must have a strong knowledge of ICH/GCP guidelines and regulatory requirements
    • Must have strong knowledge of clinical drug development processes including technical document review and preparation (protocols, clinical study reports, etc.), clinical study design, study planning, management, and monitoring.
    • Requires proven project management skills in clinical research and study leadership ability
    • Must have excellent interpersonal, written, verbal , presentation, administrative and computer skills
    • Fluent in English (oral and written). Moderate (25%) travel required
    • *Candidate is required to work on-site in Northbrook*