Senior Clinical Risk Manager

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.

ICON is currently hiring for a Senior Clinical Risk Manager to join our Risk Based Quality Management team as people leader and line manager for RBQM.

Candidates should have strong knowledge of Risk Based Quality Management, Risk Based Monitoring, and Central Monitoring requirements in the Pharma or CRO industry. Line Management experience preferred.

We are looking for someone with excellent people leader, coaching skills and critical thinking skills, to support team governance, development and growth.

Main job functions/responsibilities will be as follows: Executes the responsibilities of disciplined adoption and robust implementation of ICON's Risk Based Quality Management across ICON and with customers, communicating with clarity.Deliver and maintain client-focused reporting to measure performance and proactively identify issues.Drives and implements change management, process review & design as well as development of effective training.Prepare, design and present or support at proposals, bid defences, KOMs, Sponsor Audits.Contributes to the development and implementation of the services of the Clinical Efficiency, Quality and Prevention in support of PMOG and Project Management, establishing standards and maintaining systems to measure quality/risk in performance against the established standards.Plans and Manages disciplined and robust implementation of Clinical Risk Management, supporting Risk assessments; monitors effectiveness of Risk Identification, Risk Mitigation and Risk Prevention approaches.Makes independent decisions that have impact on the services and clinical trials regarding the Risk Based Quality Monitoring strategy.Provide lessons learned and expertise, as relevant.Liaise and co-operate with IT, Clinical Data Services, Quality Assurance in determining strategies and technologies to address Risk and Opportunities for the development of new business.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 activitiesEstablish and maintain necessary communication strategy for the improvement and awareness of quality issues across all departments.Act as Enterprise level lead and provide expert RBQM and RBM knowledge for agreed key client partnership accounts.Makes sound decisions based on available information in order to contribute to the success of ICON.

To be successful you will need:University/Bachelor's Degree in medicine, science or equivalent degree/experience.Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring.8+ years experience in Clinical Research with 4+ years experience in central monitoring and line management, or relevant skillset.Fluent in written and spoken English

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 through the form below.