CLINICAL QUALITY MANAGER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: July 15, 2024 - The Clinical Quality Manager ensures compliance with good documentation practices and effective version control. This role leverages a risk-based quality management system, conducts audits, and authors SOPs to maintain clinical standards. With substantial experience in supervising clinical quality programs, the manager excels in project leadership and adapting to diverse working environments.

Essential Hard and Soft Skills for a Standout Clinical Quality Manager Resume
  • Quality Management
  • Regulatory Knowledge
  • Document Control
  • Risk Assessment
  • Quality Audits
  • Data Analysis
  • SOP Creation
  • Project Management
  • Technical Writing
  • Pharmacovigilance.
  • Leadership
  • Effective Communication
  • Problem Solving
  • Quick Adaptability
  • Detail Orientation
  • Interpersonal Skills
  • Patience
  • Time Management
  • Listening Skills
  • Stress Management

Summary of Clinical Quality Manager Knowledge and Qualifications on Resume

1. BS in Healthcare Administration with 4 years of Experience

  • Demonstrable, working knowledge of global In vitro Diagnostic Regulations
  • Experience in clinical regulations, standards, guidelines and best practice e.g. CFR 812, BIMO, ISO standards, ICH guidelines
  • Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB audit
  • Ability to work cross-functionally
  • Excellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485)
  • Ability to work independently while exercising good judgement and decision making within defined practices and policies.
  • Proficient in reading, analyzing and interpreting scientific and technical information
  • Ability to demonstrate and convey high performance, high standards culture
  • Skills in MS Office packages (e.g. Excel, Word, Outlook, PowerPoint, Project)

2. BS in Public Health with 5 years of Experience

  • Registered nurse practitioner or physician assistant with license to practice in one or more state
  • Experience delivering clinical care
  • Professional work experience in technology, healthcare, or customer support
  • Exceptional written and verbal communication skills
  • Experience in performing quality assurance on physician practice
  • Experience in conducting data analysis to measure performance and identify opportunities for improvement
  • Experience mentoring, coaching, or managing staff
  • Prior healthcare operations/administration experience
  • Able to work a schedule that includes evenings and weekends
  • Aptitude, training, and experience in clinical informatics

3. BS in Health Informatics with 6 years of Experience

  • Previous experience as a CRA, or experience managing CRAs
  • Experience and knowledge of quality management and the control tools required
  • Demonstrated experience in leading cross-functional teams
  • Project management skills including a solid track record of initiating, planning and delivering projects
  • Experience in managing audits and inspections is highly desirable, as is experience in delivering training
  • Strong oral and written communication and people management skills
  • Excellent teamwork and leadership skills, with the ability to exert influence to achieve results at all levels of clinical research management
  • Ability to analyse, interpret, and solve complex problems
  • Ability to think strategically and be creative/innovative
  • Fluency in English and Turkish
  • Ability to work office based in Istanbul

4. BS in Health Sciences with 7 years of Experience

  • Subject matter expertise in clinical quality management processes and systems
  • Knowledge of study conduct and drug/biologic development process for Phase 1-3 clinical trials conducted under Investigational New Drug Applications (INDs), from pre-initiation through study closure and final data analysis.
  • Expert knowledge of ICH-GCP guidelines, US Code of Federal Regulations, and US FDA guidance documents as they relate to Quality Management and Quality Systems
  • Expert knowledge of good documentation practices (GDP) and version control
  • Experience in quality management including use of a risk-based quality management system approach, performing quality audits, and authoring SOPs
  • Ability to work independently while maintaining project timelines
  • Experience working with clinical quality management systems
  • Excellent oral and written communication skills
  • Proficiency in Spanish is valued
  • Ability to adapt to a dynamic environment and strong leadership and project management capabilities
  • Ability to identify innovative pathways to achieve objectives
  • Solid judgment, reasoning, and planning
  • Good listening skills, patience, and composure
  • Comfortable and ability to work successfully in different countries and cultures
  • Experience with supervision of clinical quality programs
  • Experience with TMF audits, including the use of Veeva Vault’s electronic Trial Master File (eTMF)
Relevant Information
Clinical Quality Analyst Skills, Experience, and Job Requirements