Senior Global Clinical Auditor
Company Name:
Advancement Agents
Position
Responsibilities:
Conduct, on a global level, GCP audits of clinical studies, suppliers, and documents (such as protocols and its associated documents) 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 complex, important, or multiple projects on a regional or trans-regional basis: interact with product development teams (in particular, the GCL) to identify and characterize new clinical studies as potential candidates for audit, proactively advise the GCL of audits planned and conducted, and of any significant quality issues arising from the audit program for individual studies interact with study managers to develop and refine audit plans interact with the Head, GSAM 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.
Lead or participate in Global System Audit teams including the development of the audit plan, training the audit team, developing tools for conducting such audits, managing the team during the conduct of the audit, and reporting the results to Global Functional Heads. The leader of a Global System Audit Team ensures timely completion of all audit related activities.
Participate in compilation of GCP Quality Reports to identify problem areas in clinical drug development participate in developing process improvement recommendations for both Global Development and Clinical Sciences. Proactively contacts the local clinical department to arrange a presentation of the data, makes the presentation and advises on areas of improvement.
Lead or participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by Global Development Quality (GDQ) management (e.g., as chair of an inspection committee, serving as an Inspection Committee member, advising on preparations for inspections, 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 GDQ for internal and external customers (e.g., new hires and consultants to Clinical Development, suppliers, and clinical investigators at Investigator Meetings).
Act as a coach/mentor in the development of less-experienced auditors.
Qualifications:
Education: Requires a BS in a biomedical science, or equivalent education with at least 8 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience.
Experience: The position requires a minimum of 5 years of clinical research related activities (e.g., monitor, study coordinator) and a 2-3 year proven record in GCP auditing activities. An in-depth 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 needed.
Competencies: 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 Pharma staff up to and including Sr. Vice President level and with clinical investigators, providers of services to 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. Proven 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 Pharma as a multinational corporation.
This position involves approximately 15 25% regional and global travel.
Salary and grade level will be commensurate with experience and/or education level. Estimated Salary: $20 to $28 per hour based on qualifications.
Advancement Agents
Position
Responsibilities:
Conduct, on a global level, GCP audits of clinical studies, suppliers, and documents (such as protocols and its associated documents) 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 complex, important, or multiple projects on a regional or trans-regional basis: interact with product development teams (in particular, the GCL) to identify and characterize new clinical studies as potential candidates for audit, proactively advise the GCL of audits planned and conducted, and of any significant quality issues arising from the audit program for individual studies interact with study managers to develop and refine audit plans interact with the Head, GSAM 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.
Lead or participate in Global System Audit teams including the development of the audit plan, training the audit team, developing tools for conducting such audits, managing the team during the conduct of the audit, and reporting the results to Global Functional Heads. The leader of a Global System Audit Team ensures timely completion of all audit related activities.
Participate in compilation of GCP Quality Reports to identify problem areas in clinical drug development participate in developing process improvement recommendations for both Global Development and Clinical Sciences. Proactively contacts the local clinical department to arrange a presentation of the data, makes the presentation and advises on areas of improvement.
Lead or participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by Global Development Quality (GDQ) management (e.g., as chair of an inspection committee, serving as an Inspection Committee member, advising on preparations for inspections, 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 GDQ for internal and external customers (e.g., new hires and consultants to Clinical Development, suppliers, and clinical investigators at Investigator Meetings).
Act as a coach/mentor in the development of less-experienced auditors.
Qualifications:
Education: Requires a BS in a biomedical science, or equivalent education with at least 8 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience.
Experience: The position requires a minimum of 5 years of clinical research related activities (e.g., monitor, study coordinator) and a 2-3 year proven record in GCP auditing activities. An in-depth 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 needed.
Competencies: 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 Pharma staff up to and including Sr. Vice President level and with clinical investigators, providers of services to 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. Proven 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 Pharma as a multinational corporation.
This position involves approximately 15 25% regional and global travel.
Salary and grade level will be commensurate with experience and/or education level. Estimated Salary: $20 to $28 per hour based on qualifications.
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