Global Clinical Auditor

Major Responsibilities

• Conduct, on a global level, GCP audits of clinical studies, suppliers, and documents (such as protocols, Clinical Study Reports) to assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures.  This will include interviews with, and feedback to, Principal Investigators, who may be key opinion leaders in a particular therapeutic area. Provide timely feedback by means of the audit report, assess and approve corrective/preventive actions proposed by responsible parties, and contribute quality compliance data for metrical analysis.
• Manage clinical study site and supplier audit activities for key compounds. This will include managing less complex projects on a regional or trans-regional basis:  interact with study managers to develop and refine audit plans; interact with the Study Audit Lead to ensure agreement, tracking, and fulfillment of the audit plan; develop audit tools (such as checklists); review draft audit reports; and prepare and distribute the Study Audit Summary report summarizing all significant study audit findings. Provide audit certificate for Clinical Study Reports.
• Participate in Global System Audit teams by assisting in the development of the audit plan, and in the development of tools for conducting such audits, participating in the conduct of the audit and the reporting the results.
• Proactively contacts the local clinical department to arrange a presentation of the GCP Quality data makes the presentation and advises on areas of improvement.
• Participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by Global R&D Quality management (e.g., serving as an Inspection Committee member, conducting pre-inspection audits, and/or serving other roles as defined by the Inspection Committee) to promote the successful outcome of the inspection.
• Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GCP standards.  This often involves sponsorship of issues for global QM consensus or acting as the primary GCP consultant for quality system Expert Working Groups.
• Support the development and refinement of the Global Quality System by leading or participating in SOP/OM authorship or review teams.
• Conduct training on the audit process and other processes owned by GR&DQ for internal and external customers (e.g., new hires and consultants to Clinical Development, suppliers, and clinical investigators at Investigator Meetings).

Requirement

• Requires a BS in a biomedical science, or equivalent education with at least 5-6 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 4-5 years of pharmaceutical industry experience
• The position requires a minimum of 4 years of clinical research related activities (e.g., monitor, study coordinator) or in a Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) auditing environment. A basic knowledge and experience in the application of good clinical practice (GCP) requirements is required (e.g., ICH, FDA, etc), as is familiarity with the essential documents related to clinical studies.  The incumbent should be familiar with medical terminology and routine medical tests and procedures.  Familiarity with computerized clinical data collection systems and biomedical statistics is helpful.
• The incumbent must possess strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results. Oral and written proficiency in the English language is required.  Incumbent must also be confident and adept in the use of computerized databases and other applications. Professionalism is mandatory as the incumbent must interact directly with all levels of Bayer Schering Pharma staff up to and including Sr. Vice President level and with clinical investigators, providers of services to Bayer Schering Pharma and others.  The ability to develop interdepartmental relationships is critical.  Incumbent must be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues, such as instances of serious clinical noncompliance. Good project management skills, including effective planning and organizational skills, attention to detail and excellent follow through. The incumbent must be aware of the key differences in how business is practiced various countries to work effectively with various cultures.  It is essential to be aware of the key cultural customs and practices that will create an effective working relationship and effectively represent Bayer Schering Pharma as a multinational corporation. This position involves approximately 40 – 50% global travel.