Senior Clinical Auditor (GCP)

  • Full time
  • Prague
  • Posted 2 weeks ago

Role: Senior Clinical Auditor (GCP)

Location: Central/South European location options (up to 35% travel)

Poland, Czech Republic, Hungary, Italy, Romania, Spain, – these are all good option locations to be based from (Remote working is available)

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

We are seeking a Senior Auditor to join our global Clinical Quality Assurance team in ICON Quality & Compliance.

Our ICON Clinical QA (CQA) team is seeking a Senior Auditor candidate that is very keen on joining a passionate and highly inclusive team of QA professionals. Not only will you bring your own experience and knowledge to us, our Team will also keenly share its passion, expertise and knowledge with you! You will have lots of opportunities to partner with other highly skilled ICON professionals through an interesting variety of activities. From the moment you start your new position with us, our Team will support and encourage you to grow beyond it.

With excellent knowledge of GCP and a solid experience in conducting clinical QA audits, as a Senior Auditor in our Clinical Quality Assurance team you will represent ICON Quality & Compliance in partnering with diverse service lines and operational departments, which are primarily involved in service provision for Phase II-IV and Late Phase studies / activities.

Your key responsibilities and tasks will include the following:

Auditing responsibilities:

  • Assisting CQA management with and/or oversee the assigned internal audit schedule

  • Planning and conducting regular clinical internal audits as assigned (project, site, process audits) as well as assigned contracted audits, for cause audits, vendor and sub-contractor audits.

  • Reporting the results of the audit and any relevant findings and track them into the ICON systems as requested.

  • Reviewing audit responses by the auditees. Follow up all outstanding replies and escalate issues to the relevant management for action.

  • Training, mentoring and developing less experienced QA auditors

  • Business Partnering responsibilities:

  • Provide support to CQA management in business partnering with assigned service line/departments (e.g. through regular meetings and related preparation/ follow-up of actions)

  • Partner with relevant business service lines / departments in facilitating compliance with Quality Management System / Quality Assurance program (e.g. CAPA support).

  • This also may include liaising with clients in support of contracted audits or other quality / compliance related matters.

  • Support SOP/Process documentation review as assigned by management

  • This role would require travel primarily across the EMEA region (up to 35%), on occasion this may increase depending on business needs.

    Experience and skills for the role:

  • Solid Clinical Audit experience

  • Excellent knowledge of GCP and related clinical trial regulations

  • Able to operate under moderate supervision and direction

  • Excellent verbal and written communication skills and interpersonal skills, with fluent written and spoken English language skills

  • Understand key business drivers; uses this understanding to accomplish own work

  • Excellent organizational skills

  • Excellent interpersonal skills

  • To apply for this job please visit cz.talent.com.