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Senior Global Clinical Auditor

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, (Senior Global Clinical Auditor), are to: 

 

  • Conduct, on a regional level, good clinical practice audits of clinical studies, suppliers, and documents (such as protocols, informed consent, monitoring plans, etc.);
  • 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;
  • Participate in periodic compliance metrics trending to identify problem areas in clinical drug development; participate in developing process improvement recommendations for audit metrics and presentes data to the local medical department;
  • Participate in regulatory authority pre-, during-, and postinspection activities as needed and requested by research & development management (eg,working alongside a Senior Global clinical auditor as an inspection committee member, providing basic advice on preparations for inspections, assisting in the conduct of preinspection audits, and/or serving other roles as defined by the inspection committee or rdq 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 Administration, Internal Council for Harmonisation, etc.) And company procedures and policies, proactively maintaining cognizance of current good clinical practice standards;
  • Support the development and refinement of the global quality system by participating in standard operationg procedure / OI review teams;
  • Conduct training on the audit process and other processes owned by research & development for internal and external customers (eg, to medical development, suppliers, and clinical investigators at investigator meetings).

 

.pre {white-space: pre-wrap;} Who you are

 

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:

 

Required Qualifications:

  • Bachelor's of Science degree required (in a life science preferred) with at least eight (8) years of pharmaceutical industry experience, or a Master's of Science degree (in a life science preferred) with at least seven (7) years of pharmaceutical industry experience;

  • Minimum of five (5) years of clinical research related activities (eg, monitor, study coordinator) and a two to three (2-3) year proven record in good clinical practice auditing activities;

  • An indepth knowledge and experience in the application of good clinical practice requirements is required (International Council for Harmonisation, Food & Drug Administration, etc), as is familiarity with the essential documents related to clinical studies;

  • Familiarity with medical terminology and routine medical tests and procedures, computerized clinical data collection systems, and biomedical statistics is needed.

  • 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;

  • Must 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.

  • 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;

  • Ability to travel approximately 20-30% in North America and Latin America, and elsewhere as required.

 

.pre {white-space: pre-wrap;} 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.