Clinical Compliance/Inspection Readiness, Manager - Clinical Operations
$107250/y-$178750/y
Immunocore3 days ago
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OnsiteFull-timeSenior
Summary
Immunocore is seeking a Clinical Compliance/Inspection Readiness Manager to join their Clinical Operations team in Radnor, PA. The role involves managing inspection preparedness, clinical procedural development, and compliance training programs.
About the Role
As a Clinical Compliance/Inspection Readiness Manager, you will lead the development and delivery of GCP and Inspection Readiness training, implement processes to support inspection readiness, and provide ongoing support to study teams. You will coordinate audit preparations, manage inspection responses, and drive continuous improvement in compliance practices. Additionally, you will oversee the development of controlled documents and collaborate with Quality Assurance on compliance assessments.
About You
Required:
- At least 8 years of relevant experience in the biotechnology/pharmaceutical industry or contract research organization (CRO) with a focus on compliance, quality, or clinical operations.
- Expertise in global regulatory and compliance requirements for clinical research, including US CFR, EUCTD, and ICH GCP.
- BA/BS or higher in a science-related field (biological science, medical, pharmacy, or other health-related discipline).
Preferred:
- Experience in clinical auditing and relevant clinical operations functions.
- Experience in QA/Audit settings.
- Demonstrated computer skills with proficiency in Microsoft Office applications.
Benefits
- Competitive salary range of $107,250-$178,750.
- Opportunities for professional development and continuous learning.
- Inclusive workplace culture that values diversity and collaboration.
Immunocore
Immunocore is a leading T cell receptor (TCR) biotechnology company working to create first-in-class biological therapies to address unmet patient needs in oncology as well as infectious and autoimmune diseases. See our community guidelines: http://bit.ly/2kFA8hr
Radnor, PA