Назад
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11 часов назад

Quality Manager, Clinical

62 800 - 216 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Manager, Clinical (GCP/Clinical Research): Developing and implementing quality management and risk management plans for clinical research delivery with an accent on country and site-level compliance oversight, GCP adherence, and CAPA management. Focus on conducting site assessments, supporting audits and regulatory inspections, driving inspection readiness, and managing quality issues across clinical teams.

Location: San Francisco, CA, United States of America

Salary: $62,800–$216,000 annualized base pay

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Conduct country- and site-level compliance oversight using a risk-based approach.
  • Identify compliance risks, perform site assessments, and manage corrective and preventive actions.
  • Implement quality management and risk management plans for assigned delivery units, sponsors, and business lines.
  • Advise clinical teams and stakeholders on Good Clinical Practice compliance and quality control.
  • Support audits, regulatory inspections, inspection readiness, and investigations of suspected misconduct.
  • Prepare periodic reports on quality matters, risk assessments, and improvement initiatives.

Requirements

  • 9+ years of total experience with a clinical operations background and GCP/compliance experience.
  • Strong experience in site oversight, risk management, and quality issue resolution.
  • Bachelor’s degree or equivalent combination of education, training, and experience.
  • Working knowledge of medical terminology, ICH, GCP, SOPs, regulatory requirements, quality management processes, and drug development.
  • Knowledge of CRO or pharmaceutical industry operations and clinical research standards.
  • Fluent English required; ability to travel within the region or country.

Nice to have

  • Oncology experience.

Culture & Benefits

  • Collaboration with global or regional quality management, clinical, business, and quality assurance teams.
  • Health and welfare benefits may be offered depending on the position.
  • Incentive plans, bonuses, or other compensation may be available depending on the position.
  • Equal opportunity employment environment.

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