ERGOMED is hiring a
GCP Consultant

Summary

Join ADAMAS, a leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. We are seeking an experienced professional to deliver projects in compliance with agreed project proposals, project/audit plans, applicable regulations, and agreed timelines.

Requirements

• 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

Responsibilities

• 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