Inspection Readiness Coordinator

summit, New Jersey
Apply with System One

Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 138519

Date Posted: 03/15/2019


Job Title: Inspection Readiness Coordinator

Location: Northern New Jersey

Employment: Direct Hire, salaried with benefits

Responsibilities:

  • Lead some clinical operations sub-teams through the activities of preparing for worldwide health authorities inspections following marketing applications
  • Managing team meetings
  • Develop agendas, track actions, and communicate meeting outcomes.
  • Ensure plans are implemented in accordance with timelines and any issues are escalated for resolution in a timely manner
  • Do practical work to document history, build storyboards, etc.
  • Help project manager in leading activities related to inspection readiness preparation
  • Assist project manager in evaluating trials and potential inspection risks/mitigations

Qualifications:

  • BS Life Sciences
  • 3+ years project management experience (doesn’t have to specifically have a PM title, just experience managing timelines, budget and deliverables within a functional group listed below)
  • Knowledge of clinical operations, quality assurance, and quality management
  • Previous experience preparation with FDA/other Regulatory inspections
  • Experience with global clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements. and BIMO guidance
  • Experience with clinical trials, including vendor management
  • Exceptional oral and written communication skills
  • Certification in project management (PMP, CAPM) is desired but not required

Apply with System One