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Job type: Contract

Discipline: Good Clinical Practice (GCP)

Location: United States

Clinical Quality Compliance Lead - Contract - Cambridge, MA

Proclinical is seeking a Clinical Trial Quality Oversight Specialist to ensure excellence in clinical trial delivery through robust quality systems. This role focuses on operational and compliance excellence, quality risk management, and knowledge management. You will play a crucial part in maintaining control and alignment with regulations, while partnering with various functions to identify and mitigate quality and compliance risks.

Skills & Requirements:

Strong understanding of quality systems and regulatory requirements in clinical trials.
Experience in quality risk management and compliance.
Ability to conduct thorough investigations and develop effective CAPAs.
Excellent collaboration and communication skills.
Strategic thinking and problem-solving abilities.

The Clinical Quality Compliance Lead will:

Oversee quality systems for clinical trial delivery, ensuring alignment with regulations.
Implement monitoring and control systems to maintain quality standards.
Collaborate with different functions to identify and address systemic quality and compliance risks.
Conduct investigations and develop corrective and preventive actions (CAPAs).
Manage changes and facilitate continual improvement aligned with strategic priorities.
Act as a strategic partner to the Head of GCP Quality Compliance in developing and implementing compliance strategies.
Support operational activities and capability building within the GCP Compliance function.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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