TANNER & ASSOC INC
Senior Global Clinical Auditor—New Jersey
TANNER & ASSOC INC, Trenton, New Jersey, United States
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 yearspharmaceutical 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
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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 yearspharmaceutical 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
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