Quality Monitoring & Compliance - Remote
- United States
- Clinical Trial Support
- ICON Strategic Solutions
- Remote
About the role
This vacancy has now expired. Please see similar roles below...
Develops and maintains quality monitoring plans for assigned programs. Executes and/or oversees the implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. Ensures agreed upon deliverables are completed within the timeframe established, including but not limited to review and assessment of Quality Risk Management reports; coordination of quality risk mitigation plans for identified issues; quality reviews of key clinical trial documents, and review and planning of submission activities as needed.
Supports Due Diligence activities, as requested, liaising with the applicable business and R&D Q&C L&A coordination personnel. Provides Good Clinical Practices (GCP) guidance to workgroups and to business partners. Ensure interpretation and consistency with compliance guidance provided. Assists in the facilitation of inspections by regulatory authorities for GCP, supporting R&D Q&C as appropriate.
What you will be doing:
- Provides appropriate QM&C support to assigned cross-functional workgroups.
- Responds independently to GCP-related compliance inquiries from other departments. Confers with quality professional staff when contacted for pro-active consultation to provide regulatory insight.
- Manages inspection preparation activities and supports business during health authority inspections, in liaison with R&D Q&C as appropriate.
You are:
- Advanced: minimum of 8 years of business experience
- Ability to motivate professional colleagues and stakeholders
- Conflict resolution/management and negotiation skills
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks
- Experience of the key customers’ business processes and practices; experience of the overall drug development process is an asset
- Knowledge of the overall drug development process;
- Strong working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
- Experience with regulatory submissions (NDA, BLA);
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, 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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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
Career ProgressionContent type
BlogsPublish date
07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
Teaser label
Our PeopleContent type
BlogsPublish date
02/28/2023
Summary
John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
by
John Bailey
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
Who we are
Similar jobs at ICON
Salary
Location
Warsaw
Department
Clinical Operations Roles
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-109680
Expiry date
01/01/0001
Salary
Location
Boston
Department
Clinical Operations Roles
Location
Boston
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-109962
Expiry date
01/01/0001
Salary
Location
Netherlands, Amsterdam, Schiphol
Location
Amsterdam
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
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
JR119275
Expiry date
01/01/0001
Author
Rajkapoor KamaludeenAuthor
Rajkapoor KamaludeenSalary
Location
Poland, Warsaw
Department
Full Service - Development & Commercialisation Solutions
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
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
JR116855
Expiry date
01/01/0001
Author
Moushami RoyAuthor
Moushami RoySalary
Location
Poland, Warsaw
Department
Full Service - Development & Commercialisation Solutions
Location
Sofia
Warsaw
Barcelona
Madrid
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
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
JR117450
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Madrid
Department
Clinical Operations Roles
Location
Madrid
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-109584
Expiry date
01/01/0001