Job Description

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.



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:

\xe2\x97\x8f Executing audits based on experience and a comprehensive understanding of all federal regulatory requirements and guidance on Good Clinical Practice (GCP).

\xe2\x97\x8f Performing GCP quality assurance projects which fall within your areas of expertise on behalf of client companies within the pharmaceutical/biotechnology industry

\xe2\x97\x8f Contributing to the upskilling of consultants in the conduct of vendor and systems audits

\xe2\x97\x8f Assisting with business development activities

\xe2\x97\x8f Performing other reasonable duties as requested by the job holder\xe2\x80\x99s Line Manager

Qualifications

\xe2\x97\x8f BSc in Life Science Preferred

\xe2\x97\x8f Experience in conducting and leading internal and external GCP audits for a variety of stakeholders

\xe2\x97\x8f Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)

\xe2\x97\x8f Experience in conducting GCP systems audits

\xe2\x97\x8f Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site

\xe2\x97\x8f Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage

\xe2\x97\x8f Expert knowledge of national and international GCP legislation and guidelines

\xe2\x97\x8f Proficient in managing projects and ensuring deliverables are provided on time

\xe2\x97\x8f Ability to identify issues and offer solutions in a pragmatic way

\xe2\x97\x8f 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.

Adamas Consulting