Senior Global Clinical Auditor—New Jersey

Senior Global Clinical Auditor—New Jersey

Tanner and Associates is recruiting a Senior Global Clinical Auditor for a Pharmaceutical company based out of New Jersey.

Responsibilities:

• Conducts global GCP audits of clinical studies, Protocols, Medical Research Reports and suppliers
• Assesses compliance of clinical investigations and internal processes
• Manages clinical study site and supplier audit activities for key drug compounds on a regional and trans-regional basis.
• Interacts with Study Managers to develop and refine audit plans
• Interacts with Global Study Audit Manager to track and complete audit plan.
• Develops audit tools, reviews draft of audit reports, and prepares and distributes the Study Audit Summary Report
• Leads Global System Audit teams to develop, conduct, and report results to the Global Functional Heads.
• Improves processes for Development & Compliance and Clinical Pharmacology audit metrics.
• Leads regulatory inspection activities and serves as an inspection committee member
• Provides interpretation and guidance for internal and external customers on clinical quality regulations/guidelines (FDA, ICH, EU, etc.)
• Supports development and refinement of the Global Quality System by participating in SOP authorship.
• Conducts training on the audit process for internal and external customers
• 40-50% international travel

Requirements:

• BS in biomedical science or equivalent with 8 years pharmaceutical industry experience; or, a MS in biomedical science or equivalent with 5 years of pharmaceutical industry experience.
• Minimum of 5 years of clinical research experience and 2-3 years of GCP auditing experience.
• Knowledge and experience of GCP requirements
• Familiar with computerized clinical data collection systems and biomedical statistics
• Proven project management skills including effective planning and organizational skills.
• Must be willing to travel approximately 40-50% to North America, Latin America, Australia and elsewhere

Please send a CV and contact information to Jake Tanner at careers@www.biotechsearch.com .  US candidates only please.

Thanks,

Jake Tanner

Tanner & Associates

Careers@www.biotechsearch.com

760.598.3363