Clinical Quality Compliance Specialist
About the role
This vacancy has now expired. Please see similar roles below...
Clinical Quality Compliance Specialist / Clinical Quality Compliance Lead
ICON Plc is a leading Clinical Research Organisation headquartered in Leopardstown, Dublin 18. Founded in Dublin in 1990 with a team of 5, ICON Plc now employs over 13,000 people in 38 countries.
ICON is currently seeking a Clinical Quality Compliance Specialist / Clinical Quality Compliance Lead to join the Clinical Quality Compliance team. You will act as an ICH GCP and ICON/Client SOPs/WPs expert, quality compliance advisor and leader on all stages of study set-up, monitoring and study close-out for assessment and oversight of clinical quality compliance processes for monitoring activities.
This is a fantastic opportunity to join ICON and to work with one of our largest clients on a global level.
The role:
- Act as Case Lead for the Significant Quality Events (SQEs) in PSBU, help with root-cause analysis and creation of Corrective and Preventative Action Plans (CAPAs), conduct CAPA verifications and CAPA effectiveness checks.
- Supports study teams in preparations and follow-up on site audits, conduct CAPA reviews and CAPA verifications
- Assist the relevant operational staff (Clinical Trial Managers, Project Managers and Project Directors) in the development and implementation of clinical quality plans at the department and study level.
- Assist project/portfolio teams with assessment of quality metrics, SQE trends, Protocol Deviations, Site Health issues, Clinical Quality Risk Management plans and/ or key quality/performance indicators.
- Identify, escalate and mitigate potential quality issues, GCP violations and non-compliance with internal or client SOPs/processes on project/portfolio/department level.
- Assisting project/portfolio teams with quality control processes ensuring that the agreed study monitoring plan is followed and any issues are resolved or escalated 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.
- Assisting in investigation and detection of the quality issues and development of CAPAs for the project/portfolio/department when required.
- Scheduling and managing internal and external meetings, producing presentation/s training materials and generating meeting minutes.
- Preparation and distribution of regular status reports (e.g., trends in Clinical QC findings) both internally and externally
- Training/Mentoring of new/less experienced Clinical Quality Compliance staff on processes and procedures.
- Provide QC services to other operational departments/vendors, as required.
- Occasional travel domestic and/or international
- Hold a bachelor’s Degree/ M.Sc./ Ph.D. (advanced degree desired)
- Have significant CAPA experience (management of SQEs/audits).
- In depth proven relevant health care industry experience (Pharmaceutical Company / CRO), with at least 3 years of experience working within Quality Assurance/Control, Clinical Trial Management, Clinical Project Management or Clinical Operations/SSU Management.
- Strong leadership and relationship building skills.
- Problem solving skills and ability to deal with internal and external colleagues at varying levels of seniority, including upper management
- Excellent written and oral communications skills. A great communicator, who is able to self-confidently present in front of large audience
- Strong influencing, mentoring and coaching skills.
- Highly organised, flexible, adjustable, happy to deal with competing priorities and tight deadlines.
- PMI and/or Six Sigma Certification would be highly desirable but not essential.
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
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
Our PeopleContent type
BlogsPublish date
03/27/2024
Summary
Exploring Lucy's Path: From Science to Communications Lucy's career journey is a testament to the power of adaptability and seizing opportunities as they arise. "I've been in Clinical Research si
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Interviews can be nerve-wracking experiences, but with the right preparation, you can enter the room with confidence and increase your chances of success. Preparing for an interview is crucial a
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC
Who we are
Similar jobs
Salary
Location
Paris
Department
Clinical Operations Roles
Location
Paris
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
The Contract Specialist we are looking for will be responsible for overseeing specific clinical contract activities. The primary responsibilities include providing contract process guidance, conductin
Reference
2024-109449
Expiry date
01/01/0001
Author
Theo LambertAuthor
Theo LambertSalary
Location
Turkey
Department
Clinical Monitoring
Location
Turkey
Remote Working
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.
Reference
2023-106051
Expiry date
01/01/0001
Author
Tuba SuAuthor
Tuba SuSalary
Location
Boston
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Boston
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Quality Assurance
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
2023-107609
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
USD5 - USD10 Annually
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc est un chef de file mondial en matière de soins de santé intelligents et de recherches cliniques. De la molécule au médicament, nous faisons progresser la recherche clinique en offrant des s
Reference
2023-104717
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Turkey
Department
Clinical Monitoring
Location
Turkey
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
2023-104179
Expiry date
01/01/0001