Clinical Compliance Manager I

Lake County, IL, US
Sep 19, 2019
Required Education
Bachelors Degree
Position Type
Full time
  • Responsible for compliance with applicable Corporate and Divisional policies and procedures.
  • Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators
  • Provides input on new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.
  • Effectively communicates project progress/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues .

  • Bachelor's degree (or equivalent ex-US) is required, typically in nursing or scientific field. An Associate's degree/R.N. (or equivalent ex-US)with relevant experience is acceptable.
  • Must have 6+ years of Pharma-related/ clinical research related experience; 2+ years of experience preferably with clinical research, regulatory, compliance and/or quality control.
  • Must have demonstrated a high level of core and technical competencies through management of various aspects of clinical trials (e.g., audits, study oversight, SOP development, quality assessments)
  • Possesses good communication skills, demonstrated leadership abilities and problem solving skills.
  • Demonstration of successful coaching/ mentoring in a matrix environment
  • Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
  • Preferred global exposure from study initiation through study completion in multiple phases of studies (Phase 1-3, 4) .