QA Manager - Clinical Trials

CY Partners
Newcastle upon Tyne
£39000 - £46000/annum Excellent Benefits
10 Jun 2017
10 Jul 2017
Contract Type
Full Time
QA Manager
An excellent opportunity has arisen for an experienced QA Manager to join a prestigious clinical trials unit in Newcastle on a permanent basis. Providing expert advice on all aspects of governance of clinical trials, this is a key role to the unit. The ideal candidate will have substantial experience of managing clinical trials and good clinical practice (GCP), preferably gained within a non-commercial organisation, including experience in a position concerned with GCP and research governance.
Some key responsibilities of the role will include:
• To act as an expert in the regulatory, ethical, procedural and administrative aspects of clinical trials research
• Having knowledge of the current regulations governing the conduct of clinical trials, ensuring that all clinical trials are conducted according to the quality assurance requirements of Good Clinical Practice (GCP), Research Governance Framework, EU and other government legislation regulations, Data Protection legislation and any other guidelines or regulations pertaining to clinical trials
• To be accountable for the development, maintenance and on-going improvement of Standard Operating Procedures (SOPs) and other guidance tools; to provide a comprehensive Quality Management System providing specialist advice, guidance and support to ensure the implementation of minimum and best practice standards. To be aware of changes in regulations and ensure these are disseminated and implemented
• To implement and maintain a document management system, ensuring that NCTU policies, SOPs and essential study documents are developed, updated, controlled, circulated and utilised according to regulatory and sponsor requirements
• To maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and the sponsor on demand; to develop robust and suitably streamlined processes and procedures using examples of good practice from both inside and outside of the unit.
The successful candidate will have the following essential experience:
• Formal up to date GCP training
• In-depth knowledge and understanding of Good Clinical Practice, research governance and other legislation pertaining to clinical trials research
• Some postgraduate research or a business management qualification would be beneficial
The successful candidate will be able to display evidence of developing robust processes and procedures along with:
• In-depth knowledge and understanding of Good Clinical Practice, research governance and other legislation pertaining to clinical trials research
• Strong administrative and organisational skills
• Project management experience
• Excellent communication, networking and negotiation skills
• Able to work with clinical, academic and management colleagues at all levels
• Effective report writing and presentation skills
Overall this is a great opportunity to join a clinical trials unit currently managing around 60 trials. It is crucial that applicants have a good grasp of the scope of the role, as they will need to be able to start the role with limited training. Please apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information