Clinical Quality Compliance Specialist
About this role
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Clinical Quality Compliance Specialist at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
You will contribute to quality assurance and compliance activities, taking responsibility for your deliverables and working collaboratively.
Key responsibilities include:
- Assisting in the development and implementation of quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies.
- Participating in internal and external audits and inspections, supporting preparation, documentation, and response activities.
- Conducting quality reviews of clinical trial documentation, protocols, and study reports to identify areas for improvement and ensure adherence to quality standards.
- Collaborating with cross-functional teams to address quality issues, implement corrective and preventive actions, and drive continuous improvement initiatives.
- Providing support and guidance to colleagues on quality compliance matters, promoting awareness and understanding of quality standards and best practices.
Your Profile:
You will bring relevant quality assurance and compliance experience, along with the following qualifications and skills.
Required qualifications and experience:
- Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field.
- Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry.
- Knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.
- Strong attention to detail and analytical skills, with the ability to review and interpret complex documentation and data.
- Excellent communication, organizational, and problem-solving skills, with the ability to work effectively in a team environment.
- Willingness to travel as required (approximately 65%)
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Company at a glance
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Top Benefits
- Competitive base salary
- Performance related incentives
- Medical coverage
- Dental coverage
- Vision coverage
- Retirement plans
- Pension plans
- Life assurance
- Disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and development opportunities
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