Clinical Quality Associate Director

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.

Act as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study set-up, monitoring, and study close-out for assessment of quality compliance processes for monitoring activities.• Become involved, when required, in other areas of services and staff training and contribute to the review of companys systems and quality procedures as appropriate.• Assist in tracking and trending departmental quality compliance in processes and departmental metrics.

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.• 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.• *Travel (to sites if required)domestic.• *Assist the relevant operational staff in the development and implementation of clinical quality plans at the department and study level.• *Assist with monitoring assessment of quality metrics and/or key quality indicators.• *Identify potential non compliance/breaks of quality control steps taken by operations as measured thru SOP, WP and industry standards• *Escalation as appropriate to senior management with proposed solutions• *Assessment of quality compliance processes for TMF to identify gaps, assist with corrective measures.• *Assess and assist project teams with quality control processes for monitoring trip reports and review for selected studies to ensure the monitoring plan is followed , issues are resolved an/or escalated and cycle times are achieved .• *Oversee implementation and tracking of appropriate standard metrics of quality 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.

Education,Qualifications, Skills and Experience:

• Bachelor degree in related discipline, preferably in life science, or equivalentqualification .
• At least 5 years of experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Good understanding of the drug development process and related GXP activities.
• Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring.
• Excellent organisational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to details.
• Good presentation skills.
• Integrity and high ethical standard.
• Manages change with a positive approach for self, team and the business. Sees change as anopportunity to improve performance and add value to the business.
• Excellent knowledge of spoken and written Polish & English.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally as required.

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON 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.