Clinical Quality Compliance Lead

4 tygodni temu

Poland MyGwork Pełny etat
Job Title: Clinical Quality Compliance LeadJob Description:

This role is with ICON plc, a company that values diversity and inclusion, and a member of MyGwork, the largest global platform for the LGBTQ+ business community. As a Clinical Quality Compliance Lead, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

Key Responsibilities:

  • Develop and implement initiatives and established processes to support operations in maintaining inspection readiness.
  • Provide global strategic and tactical leadership within study teams to achieve overall quality goals while maintaining inspection readiness.
  • Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials.
  • Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus.
  • Support overall quality within assigned clinical trials and submissions.

Requirements:

  • Bachelor's degree or equivalent with a strong emphasis on science or quality management.
  • Minimum of 5 years' experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
  • Minimum of 3 years' experience in a quality role.
  • Working knowledge of ICH GCP and other relevant regulatory/health authority experience.
  • Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials.

What ICON Can Offer:

  • A competitive salary.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • A Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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