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Clinical Quality Compliance Lead

Raleigh
Permanent
Reference: JR073664
Description

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.

Clinical Quality Compliance Lead

* 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 ICON systems and quality procedures as appropriate.

* Assist in tracking and trending departmental quality compliance in processes and departmental metrics.

Job Description

* Recognize, exemplify and adhere to ICON's values that center 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.

* 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 and/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.

* Prepare reports of trends in Clinical QC findings for management.

* Develop corrective and preventative action plans for the department when required.

* Train new Clinical Quality Compliance staff on processes and procedures.

* Provide CQC services to other operational departments/vendors, as required.

* Scheduling and managing internal and external meetings, assisting in the production of presentation materials, generating meeting minutes.

* Contacting external and internal individuals to collate relevant study information.

* Other duties as assigned.

Skills/Qualifications

  • Superior organizational and interpersonal skills with ability to work independently

  • Excellent communication and follow up accompanied by the ability to analyse and present data in a way to influence and change behaviour

  • High degree of professionalism, discretion, and confidentiality

  • Strong project management skills with experience in planning, facilitating, and organizing

Basic Qualifications

  • Bachelor's Degree in health or business-related field.

  • Four to six years of experience in quality measurement/improvement, patient safety, or clinical research

  • Knowledge of regulatory agency standards and requirements strongly preferred


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.

 

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