Gcp Consultant - Toronto, Canada - Adamas Consulting

Adamas Consulting

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

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Description

Company Description

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
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., fullservice 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.