Clinical Quality Compliance Lead

At ICON, it’s our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are currently seeking a 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. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

• 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

• 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.

Ongoing development is vital to us, and as a Clinical Quality Compliance Lead you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin