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Clinical Quality Compliance Lead/EU Any Location

ICON Plc is a leading Clinical Research Organisation headquartered in Leopardstown, Dublin 18. Founded in Dublin in 1990 with a team of 5, ICON Plc now employs over 13,000 people in 38 countries.
ICON is currently seeking a Clinical Quality Compliance Specialist / Clinical Quality Compliance Lead to join the Clinical Quality Compliance team. You will act as an ICH GCP and ICON/Client SOPs/WPs expert, quality compliance advisor and leader on all stages of study set-up, monitoring and study close-out for assessment and oversight of clinical quality compliance processes for monitoring activities.
This is a fantastic opportunity to join ICON and to work with one of our largest clients on a global level.
The role:
Act as Case Lead for the Significant Quality Events (SQEs) in PSBU, help with root-cause analysis and creation of Corrective and Preventative Action Plans (CAPAs), conduct CAPA verifications and CAPA effectiveness checks.
Supports study teams in preparations and follow-up on site audits, conduct CAPA reviews and CAPA verifications
Assist the relevant operational staff (Clinical Trial Managers, Project Managers and Project Directors) in the development and implementation of clinical quality plans at the department and study level.
Assist project/portfolio teams with assessment of quality metrics, SQE trends, Protocol Deviations, Site Health issues, Clinical Quality Risk Management plans and/ or key quality/performance indicators.
Identify, escalate and mitigate potential quality issues, GCP violations and non-compliance with internal or client SOPs/processes on project/portfolio/department level.
Assisting project/portfolio teams with quality control processes ensuring that the agreed study monitoring plan is followed and any issues are resolved or escalated as required.
Review of deliverables on project/portfolio/department level in conjunction with issues that are affecting the quality of the clinical deliverables to ensure quality standards are achieved.
Assisting in investigation and detection of the quality issues and development of CAPAs for the project/portfolio/department when required.
Scheduling and managing internal and external meetings, producing presentation/ training materials and generating meeting minutes.
Preparation and distribution of regular status reports (e.g., trends in Clinical QC findings) both internally and externally
Training/Mentoring of new/less experienced Clinical Quality Compliance staff on processes and procedures.
Provide QC services to other operational departments/vendors, as required.
Occasional travel domestic and/or international
The successful candidate will:
Hold a bachelor's Degree/ M.Sc./ Ph.D. (advanced degree desired)
Have significant CAPA experience (management of SQEs/audits).
In depth proven relevant health care industry experience (Pharmaceutical Company / CRO), with at least 3 years of experience working within Quality Assurance/Control, Clinical Trial Management, Clinical Project Management or Clinical Operations/SSU Management
Strong leadership and relationship building skills.
Problem solving skills and ability to deal with internal and external colleagues at varying levels of seniority, including upper management
Excellent written and oral communications skills. A great communicator, who is able to self-confidently present in front of large audience
Strong influencing, mentoring and coaching skills.
Highly organised, flexible, adjustable, happy to deal with competing priorities and tight deadlines
PMI and/or Six Sigma Certification would be highly desirable but not essential.
Benefits of Working in ICON
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.



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