Your tasks and responsibilities
The primary responsibilities of this role, Global Clinical Auditor, are to:
Who you are
- Conduct, on a global level, Good Clinical Practice audits of clinical studies, suppliers, and documents (such as protocols, Patient Information Sheet/Informed Consent Document, Monitoring) 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 less complex projects on a regional or trans-regional basis: interact with study managers to develop and refine audit plans; interact with the respective local Head of Good Clinical Practice Study Audit Management to ensure agreement, tracking, and fulfillment of the audit plan; develop audit tools (such as audit checklists); review draft audit reports; and prepare and distribute the Study Audit Summary Reports summarizing all significant study audit findings for use by the product development teams in the development of the Clinical Study Report;
- Participate in Good Clinical Practice System Audit teams by assisting in the development of the audit plans, developing tools for conducting such audits, conducting the audit, and reporting the results;
- Contacts the local medical department to arrange a presentation of the data, makes the presentation and provides general advice on process improvements;
- Participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by Global Development Quality management (e.g. working alongside a Senior Global Clinical Auditor as an Inspection Committee member, providing basic advice on preparations for inspections, assisting in the conduct of pre-inspection audits, and/or serving other roles as defined by the Inspection Committee or Global Development Quality committee representative) to promote the successful outcome of the inspection;
- Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (Food & Drug Adminstration, Inernational Council for Harmonisation, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current Good Clinical Practice standards. This often involves sponsorship of issues for Global Development Quality consensus or acting as the primary Global Clinical Practice country consultant for quality system Expert Working Groups;
- Support the development and refinement of the Global Quality System by participating in Standard Operating Procedure /OI authorship or review teams;
- Conduct training on the audit process and other processes owned by Global Development Quality for internal and external customers (e.g., new hires and consultants to Global Development, Clinical Pharmacology, suppliers, and clinical investigators at Investigator Meetings).
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Requires a Bachelor's Degree in a biomedical science, with at least five to six (5-6) years of pharmaceutical industry experience, or a Master's Degree in a biomedical science, with at least four to five (4-5) years of pharmaceutical industry experience;
- Requires at least four (4) years of experience in clinical research activities (e.g., monitor, study coordinator) or in a Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) auditing environment;
- At least one to two (1-2) year must include a proven record in Good Clinical Practice compliance activities (such as clinical trial monitoring or study coordinator activity) or audit experience within a GLP or GMP environment;
- 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;
- 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 staff, up to and including Senior Vice President level and with clinical investigators, providers of services to Bayer and others. The ability to develop interdepartmental relationships is critical;
- 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;
- Ability to travel 20-30% in the region the auditor is located, and elsewhere as required .
#KRT Your application
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Country:
United States Location:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.