GCP Consultant (GCP Auditor)

Company Description

ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).

Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an established client base with an expansive global reach, including North America, Europe, and Asia Pacific. We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies. 

At ADAMAS, our people are our primary asset. We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources. ADAMAS's success is down to the calibre of its people – to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.

Job Description

• 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

Qualifications

• 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
  

Additional Information

Why ADAMAS?

As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

• Training and career development opportunities internally

• Strong emphasis on personal and professional growth

• Friendly, supportive working environment

• Opportunity to work with colleagues based all over the world, with English as the company language.

Our core values are key to how we operate, and if you feel they resonate with you then ADAMAS, an Ergomed Company is a great place to join!

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.