Clinical Compliance Manager
Are you an experienced Clinical Trial Manager, Associate Project Manager or Lead CRA looking for the next step in your career?
Are you keen to use your site management skills to work with colleagues encouraging a proactive approach to quality management and process improvement?
Do you have a passion for training?
Are you interested in providing support across the range of clinical research services e.g. clinical operations, project management, safety reporting and data management?
If yes, then this is the job for you!
An opportunity has arisen for a motivated and experienced Compliance Manager to join our growing global Clinical Research Organization team in the United States (US). This role will provide clinical and regulatory compliance guidance and support across the clinical trials conducted by George Clinical in the US
George Clinical is a leading clinical research organization (CRO) with staff in Australia, New Zealand, China, Taiwan, Korea, Malaysia, India, the United States and Europe - we couple the medical and scientific expertise of The George Institute with operational excellence and a truly global presence. George Clinical provides a full range of trial management services to pharmaceutical, medical device and diagnostic customers, for both registration and post marketing trials. Our parent organization, The George Institute for Global Health, is a leader in chronic disease research with a global network of experts. George Clinical combines this scientific and clinical leadership from the Institute with world class trial delivery capability to create a distinctive service. George Clinical’s internationally recognized scientific leadership allows them to provide excellence from design to delivery.
The key responsibilities for the role will include:
- Provision of clinical and regulatory compliance advice to George Clinical colleagues
- 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
- Conducting quality management review activities including (but not limited to) process reviews, vendor assessments, 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
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
• Technological proficiency including Microsoft Office packages
• Ability to see the big picture, yet still focus on detail and quality of work.
We are searching for individuals who are results oriented and able to handle rapidly changing priorities in a fast moving environment. You must be willing to extend yourself, take on new challenges with a ‘can do’ attitude and work with locally and regionally based team members.
Our preferred candidates will be based in Memphis, TN or Overland Park, KS with full working rights in the United States.
On offer is a competitive compensation and benefits package, flexible working options and sound learning and development opportunities.
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We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.