Manager - Clinical Quality Compliance

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Manager - Clinical Quality Compliance

As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Qualifications:

• A bachelor's degree

• 3-6 years of Quality Compliance experience

• Travel (approximately 10-25%) domestic and/or international.

Duties:

• Assist the relevant operational staff in development and implementation of clinical quality plans at the department and study level.

• Assess quality compliance through monitoring of quality metrics and/or key quality indicators.

• Assess quality compliance processes for TMF to identify gaps and assist with corrective measures.

• Oversee assessment/trending of appropriate standard quality metrics related to clinical trial management and site monitoring and may personally conduct on-site co-monitoring visits.

• Review of deliverables in conjunction with issues that are affecting the quality of the clinical deliverables to ensure quality standards are achieved.

• Develop, complete and perform QC of reports for management.

• Identify potential non-compliances, breaks of quality control steps taken by operations as measured through SOPs, WPs and industry standards.

• Identify and mitigate potential quality issues, GCP violations and non-compliance with internal or client SOPs/processes on project/portfolio/department level.

• Escalate identified quality issues as appropriate to senior management providing proposed solutions.

• Train and mentor new Clinical Quality Compliance (CQC) staff on processes and procedures.

• Provide CQC services to other operational departments and vendors, 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.

• Schedule and manage internal and external meetings, produce presentation materials and generate meetings minutes, as needed.

• Contact external and internal individuals to collate relevant study information.

• Represent CQC department at internal and external meetings.

• Assist QA, GRC, Project Management and Clinical Operations with inspection readiness activities.

• Support study teams, departments and vendors in preparations and follow-up on audits, conduct CAPA reviews and CAPA verifications

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.