Full-Time GCP Consultant (GCP Auditor)

• Delivery of projects in compliance with agreed project proposals, project/audit plans, applicable regulations and agreed timelines
• Prepare, conduct (onsite/remote) and report Good Clinical Practice (GCP) audits of investigator sites and systems audits for sponsors, contract research organizations and vendors/service providers including but not limited to Study Management and Monitoring, Data Management, Statistics, Central Reading Services, Investigational Medicinal Product Depots, Interactive Voice/Web Response Service Providers, ECG Monitors)
• Prepare, conduct and report GCP Document Audits (example Clinical Study Report (CSR))
• Prepare, conduct and report Trial Master File (TMF) Audits 
• Prepare, conduct and report Database Audits 
• Conduct inspection preparation/readiness audits and mock GCP inspections for compliance to PMDA regulations, ICH GCP guidelines and applicable FDA/EMA Regulations
• Perform the role of Project Lead and Client Liaison, as applicable
• Project management of audit programs, as applicable
• Delivery of consultancy services e.g., GCP system reviews, vendors, QMS gap analysis and ad-hoc consultancy
• Line Management responsibilities, as applicable

• Masters Degree in Life Sciences preferred  

• Minimum five (05) years of experience in conducting and leading investigator site audits in Japan, for compliance to Good Clinical Practice (GCP), PMDA and applicable global and local regulations  

• Minimum five (05) years of experience in conducting and leading internal and external GCP Systems audits, onsite and remotely, for a variety of stakeholders (e.g., sponsors, contract research organizations, GCP Vendors etc)  

• Experience in conducting a range of service provider audits onsite and remotely (e.g. Central Laboratory, Central ECG Readers, Investigational Medicinal Product Depots, Interactive Voice/Web Response Service Providers, etc)

• Experience in conducting GCP mock inspections to Competent Authority standards, especially PMDA considered a significant advantage

• Experience in coordinating and managing PMDA inspection preparation activities for GCP process inspections both at the sponsor and investigator site

• Expert knowledge of national and international GCP legislation and guidelines  

• Up to 40% travel and ability to conduct remote audits 

• Proficiency in written and spoken English
• Ability to work independently and in teams

We offer:  

• Training and career development opportunities internally    

• Strong emphasis on personal and professional growth   

• Friendly, supportive working environment   

• Opportunity to work with colleagues based all over the world, with English as the company language.   

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