Clinical Quality Compliance Lead

Talent Acquisition Specialist
About the role
This vacancy has now expired. Please click here to view live vacancies.
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/04/2025
Summary
Cybersecurity in Clinical Data Management In clinical research, data is both a vital asset and a significant responsibility. As trials become increasingly digitised and decentralised, the protectio
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/03/2025
Summary
Finding the Specialisation for You Clinical research is a dynamic, multidisciplinary field that brings together scientific innovation, operational rigour and patient-centric thinking. While many
.png)
Teaser label
IndustryContent type
BlogsPublish date
06/06/2025
Summary
Building Connections that Drive Progress In an industry where collaboration is critical to advancing science and improving patient outcomes, networking is more than a professional courtesy - it’s
Similar jobs at ICON
Salary
Location
Sydney
Department
Clinical Operations Roles
Location
Sydney
Remote Working
Office Based
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
Clinical Trial Site Support Assistant (0.5 FTE) - EndocrinologyLocation: Blacktown (Sydney, Australia); on-site As Study Site Support Assistant, you will be joining the world's largest & most comprehe
Reference
2025-120631
Expiry date
01/01/0001
Author
Krisztina AuthAuthor
Krisztina AuthSalary
Location
Mexico
Department
Clinical Monitoring
Location
Mexico
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
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, biotech
Reference
2025-120583
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
Senior Site Contracts LeadResponsible for overall oversight, management, and delivery of site contracts for assigned studies at country, regional, or global level and other site contracting projects a
Reference
JR128419
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Contracts Administration
Job Type
Permanent
Description
Title: Site Contracts LeadResponsible for overall oversight, management, and delivery of site contracts for assigned studies at country, regional, or global level.Responsibilities:In collaboration wit
Reference
JR128195
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Administrator to join our diverse and dynamic team. As a Clinical Trial Administrator at ICON, you will play a pivotal role in assisting with the design and a
Reference
JR126281
Expiry date
01/01/0001
Salary
Location
Santiago
Department
Clinical Monitoring
Location
Santiago
Remote Working
Office Based
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with one of our
Reference
2025-120592
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda Obregon