4 часа назад
Sr. Quality Specialist (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Quality Specialist (Clinical Research): Implementing quality management plans and supporting clinical research teams with an accent on GCP compliance, risk assessment, and corrective/preventive actions. Focus on managing non-compliance, supporting audits and regulatory inspections, developing quality improvement initiatives, and applying Power Apps or AI agent development to quality processes.
Location: Reading, Berkshire, United Kingdom, with attendance at the sponsor's office in Moorgate, London three times per week. Regional or country travel may be required.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Implement global, Delivery Unit, and sponsor-specific Quality Management Plans.
- Plan and execute quality management activities, including data review, quality control, risk identification, and risk assessment.
- Support risk mitigation, corrective and preventive actions, and quality improvement initiatives.
- Advise clinical research teams and stakeholders on Good Clinical Practice compliance and quality management.
- Manage non-compliance and quality issues, escalating them to business leadership and Quality Assurance according to SOPs.
- Prepare quality reports and support audits, regulatory inspections, and suspected misconduct investigations where required.
Requirements
- Bachelor's degree or an equivalent combination of education, training, and experience.
- At least three years of clinical monitoring experience, including at least two years in a Clinical Project Manager or Clinical Team Lead-equivalent role.
- Working knowledge of medical terminology, ICH, GCP, SOPs, regulatory requirements, quality management, and drug development processes.
- Knowledge of pharmaceutical industry operations and corporate quality standards.
- Strong organizational, communication, problem-solving, judgment, decision-making, influencing, and negotiation skills.
- Fluent English required; the role is not eligible for UK visa sponsorship.
Nice to have
- Experience with Power Apps and/or AI agent development.
- Previous experience within .
Culture & Benefits
- Hybrid schedule with regular work at the sponsor's London office.
- Opportunity to collaborate with clinical research, business, and Quality Assurance stakeholders.
- Work focused on improving compliance and supporting the development of innovative medical treatments.
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