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.



Responsibilities:

• Perform GCP quality assurance projects which fall within the job holder\xe2\x80\x99s areas of expertise on behalf of client companies within the pharmaceutical industry
• Contribute to upskilling of consultants in the conduct of vendor and systems audits
• Assist with business development activities
• Perform other reasonable duties as requested by the job holder\xe2\x80\x99s Line Manager
• Leading, planning, conducting, documenting and following-up of global GCP audits according to applicable regulations, standards, quality agreements, and guidance documents
• Maintaining current knowledge of regulations, standards, guidance documents, industry initiatives and trend that impact GCP

Qualifications

Requirements:

• 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 25% travel and the ability to conduct remote audits
• Data Management Experience is a plus

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