Clinical Compliance Manager
Kansas All, Kansas
- 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
- 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