Job Details

  • Title: Clinical Compliance Manager I
  • Code: RCI-ABV-00812
  • Location: Abbott Park Illinois (IL) 60064
  • Posted Date: 08/12/2019
  • Duration: 6 Months
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  Job Description


Bachelor’s degree (or equivalent ) is required, typical in nursing or scientific field. An Associate’s degree/R.N. 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 


Purpose: 
• Person is responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trail(s); included managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics. Will matrix manage with as signed therapeutic area or functional partners to ensure proper documentation of companys procedures, implementation of process changes, ensure compliance and/or execution on timelines and quality deliverables. 
• Is aware of both internal and external business environments, assesses impact on the processes for clinical study execution and assists in making modiciaton as necessary. 
• Develops initial interpretation of relevant regulations and guidelines initiative to resolve problems and mitigate risk. 

Responsibilities: 

• 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/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions of solutions to manage the issues. 
• GCP exception management in partnership with the business: 

  • Potential nonconformity 
  • Nonconformities 
  • Planned deviations 
• Issue Escalations for potential significant non-compliance 
• Inspection support 
• Provide consultation on ad-hoc compliance questions 

Qualifications: 

• Must have demonstrated a high level of core and technical competencies through management of various aspect of clinical trails (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 (Phases 1-3, 4).