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Clinical Compliance Manager

Kansas All, KS

Post Date: 10/23/2017 Job ID: JN -102017-20288 Job Type: Clinical
Compliance Manager
  • Global Clinical Research Organisation team in the United States (US). This role will provide clinical and regulatory compliance guidance and support across the clinical trials
The key responsibilities for the role will include:
  • Provision of clinical and regulatory compliance advice to colleagues
  • Conducting quality management review activities including (but not limited to) process reviews, vendor assessments and audits, essential document and project file reviews and compliance/co-monitoring visits to study sites for the US as required
  • Verifying the implementation of corrective and preventive actions identified during conduct of internal and external audits, compliance activities and other performance monitoring activities
  • Monitoring and delivering continuous improvements to all processes under guidance from the Director, Compliance or Senior Manager, Compliance
  • Training staff in appropriate procedures, processes and systems where required and in alignment with global initiatives
  • Implementation of the training programme and framework including delivery and some development of training modules as required.

  • The ideal candidate will possess:
  • Tertiary qualifications in a health-related field, or relevant equivalent work experience
  • Strong knowledge of ICH-GCP guidelines global and US ethical and regulatory requirements for clinical research
  • Knowledge and experience with the conduct of compliance activities, site and process audits or reviews to meet GCP standards
  • At least 5 years experience in site monitoring with additional clinical operations/project management experience including phase II-IV global studies
  • Ability to coach and mentor staff in relation to non-compliance and performance issues.
  • Experience and/or qualifications in the training of clinical research staff preferred

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