GCP Consultant (GCP Auditor)

  • Toronto, ON, Canada
  • Employees can work remotely
  • Full-time

Company Description

ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.

Job Description

Our Good Clinical Practice (GCP) team of experts assist our clients in identifying the risks in their systems and processes so they can take decisive action in continuous improvement. Through the use of our extensive experience and knowledge, we help safeguard clinical development programs, bringing life-changing therapies to market faster and safer.

As a GCP Consultant, you will be responsible for planning and conducting GCP audits and clinical Mock Regulatory Inspections for our clients in line with the ADAMAS values in quality, integrity, and excellence.

Responsibilities include:

●     Executing audits based on experience and a comprehensive understanding of all federal regulatory requirements and guidance on Good Clinical Practice (GCP).

●     Performing GCP quality assurance projects which fall within your areas of expertise on behalf of client companies within the pharmaceutical/biotechnology industry

●     Contributing to the upskilling of consultants in the conduct of vendor and systems audits

●     Actively participating in the ADAMAS Learning Management System (LMS)

●     Assisting with business development activities

●     Performing other reasonable duties as requested by the job holder’s Line Manager

 

Qualifications

●       BSc in Life Science Preferred

●       Experience in conducting and leading internal and external GCP audits for a variety of stakeholders

●       Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)

●       Experience in conducting GCP systems audits

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

●       Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage

●       Expert knowledge of national and international GCP legislation and guidelines

●       Proficient in managing projects and ensuring deliverables are provided on time

●       Ability to identify issues and offer solutions in a pragmatic way

●       Ability to travel up to 40% travel and conduct remote audits

 

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.
 

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