Clinical Quality Compliance Lead
Talent Acquisition Specialist
About the role
This vacancy has now expired. Please see similar roles below...
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.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Clinical Monitoring
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109603
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
Brazil
Department
Clinical Monitoring
Location
Brazil
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You
Reference
2024-109811
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
United States
Department
Medical Affiars & Medical Writing Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109937
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan HoeySalary
Location
US, Blue Bell (ICON)
Department
Full Service - Symphony Health
Location
Blue Bell
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Engineering
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR116178
Expiry date
01/01/0001
Author
Tallulah PierreAuthor
Tallulah PierreSalary
Location
US, Portland, OR
Department
Full Service - Development & Commercialisation Solutions
Location
Portland
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Laboratory
Job Type
Permanent
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 I
Reference
JR117360
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank LampartSalary
Location
US, Salt Lake City (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Salt Lake City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinic
Job Type
Temporary Employee
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR118926
Expiry date
01/01/0001
Author
Meris MyersAuthor
Meris Myers