**Remote Senior/Principal GCP Auditor - Europe - Global CRO**
Company: Advanced Clinical Recruitment Ltd
Location: Flexible in Europe
Closing Date: 13 Feb 17
Type: Full Time
Salary (£): Competitive
Benefits: Strong Salary and Remotely Based
A leading Global CRO is actively looking for a Senior/Principal GCP Auditor to join their team, based anywhere within Europe! This role requires a professional with a Clinical background, and someone who has conducted GCP Quality Audits ideally on a Global level. The role can offer the select professional the chance to travel Globally to conduct audits as well as balance their work and personal life through flexibility. We will not be able to accept professionals without a valid European Visa.
- Perform QA audits of clinical trial data and records in order to assure compliance with the company or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO requirements.
- Assist with the implementation and maintenance of an effective Quality Assurance program.
- Assist with local project resourcing and the professional development of the QA Auditors.
Senior Principal Auditor Role:
- Effectively Plan and conduct QA audits in order to assure that clinical studies managed by the company are of the highest standard and are in compliance with requirements of company or sponsor Standard Operating Procedures, study protocols and relevant regulations.
- Maintain a thorough knowledge of all relevant company SOPs, Good Clinical Practice guidelines, relevant regulations and ISO requirements.
- Perform quality system audits and process audits.
- Perform supplier/vendor audits.
- Perform contract audits for Sponsor companies.
- Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
- Assist with the review of audit reports and audit results, and with performing analyses and trending of audit results, as required.
- Assist with the planning and coordination of specific projects related to the development and Improvement of the company Quality Assurance program
- Perform lead auditor duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results.
- Perform QA Review of SOPs, as required.
- Train and mentor new QA auditors in order for them to perform their function effectively and provide a benchmark of auditing competencies to less experienced colleagues.
- Liaise with clients and project managers on quality aspects of studies including the attendance at meetings, oral presentations and audits.
- Assist with business development activities, as required.
- Coordinate or assist with sponsor audits and regulatory Inspectors, as required.
- Assist with the management of the department when requested including local project resourcing, assignment of workload, and scheduling and review of audits.
- University/Bachelors Degree or local equivalent in medicine, science or equivalent degree/experience
- Extensive experience in Quality Assurance auditing.
- Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
- Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
- Ability to successfully implement quality plans for all phases of a trial.
- Ability to make and defend pragmatic quality decisions relating to the conduct of clinical trials.
- Good commercial awareness and customer focus.
- Detailed understanding of drug development and clinical trial process.
- Demonstrated training skills, including the ability to give constructive feedback.
- Highly developed problem resolution skills.
- Good planning and organizational skills with the ability to multi-task and prioritize effectively.
- Ability to work efficiently and independently under pressure.
- Cost consciousness.
- Ability and willingness to travel at least 35% of the time (international and domestic)
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 294 5008
LinkedIn Search: Sam Caley Quality Assurance
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