Compliance Specialist - Home Based

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, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In your role you will be responsible for performing activities within the assigned country ensuring an integrated and comprehensive quality and compliance approach for clinical trials.

At the same time, you will ensure that clinical trials are performed in compliance with local laws and regulations, industry standards and internal processes and procedures.

The role:

• Monitor compliance risk and ensure mitigation/remediation actions are defined

• Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner.

Moreover, perform the following risk- based activities:

• Conduct On-Site Compliance Monitoring Visits
• Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial
• Planning and execution of local QC checks
• Support and advise local and central study teams in root cause analysis of significant observations
• Ensure appropriate filing of the QC report

Consultation

• Provide advice regarding SOP, system and GCP questions of moderate complexity
• Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk
• Perform impact assessments of new/revised local regulations, guidance and standards
• Support central functions in ensuring local intelligence is up to date
• Support annual Due Diligence update, certification and training of local suppliers, if applicable

To be successful in the role you will have:

• A Bachelor’s Degree in Science or 4-6 years relevant experience equivalent is required.
• Knowledge of the overall drug development process
• Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities in terms of audits regarding clinical investigative sites, systems/vendors and audits of regulatory submissions
• Ability to translate data into information and strategies into executable action
• Ability to work independently
• Collaborative approach
• Highly committed to quality and compliance
• Flexible and persistent

Benefits of Working in ICON:

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.

At 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.

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, 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.