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Job Details:
Position Name : Clinical Compliance Manager
Location: Remote
Job ID : 66513ca8b3e38e96
Description : Proclinical is seeking a Clinical Compliance Manager for a leading pharmaceutical company. As the Clinical Compliance Manager you will, provide quality leadership and direction to R&D stakeholders on GCP related activities/issues and act as GCP expert/consultant for R&D colleagues.
Job Responsibilities:
Act as Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.
Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
Participate as member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
Establish relationship with CRO Quality Team member for the ongoing review of quality and compliance issues.
Skills and Requirements:
Minimum of 5 years in the academic, pharmaceutical or biotechnology industry experience, with 3+ years in a clinical compliance, quality assurance, or regulatory compliance role.
Thorough knowledge and understanding of drug development and the clinical trial process.
In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required. Working knowledge of CAPA management, risk management, regulatory inspections and GLP requirements is a plus.
Bachelor’s Degree in Business or Life sciences is required.
If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@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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