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.

This is a unique opportunity to join ICON’s Global Strategic Solutions division, assigned to a US-based Biotech with a focus on rare diseases, including Cystic Fibrosis in children and adults. You will be well supported by a local Manager who is an ambassador for internal growth and progression opportunities within the program.

Position overview:

As a Lead CRA, you will be dedicated to one of our global biotechnology clients; a client with which PRA shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in this exclusive program.

The Lead CRA is responsible for the country-level management of one or two studies from feasibility to study archive, and for communicating the progress and status of the studies to other key players within the team. Adopting a quality-focus to your work on complex global studies, your main responsibilities will include:

• Owning the study planning, progress, quality and tracking, at a country level, with full accountability for the local CRA team
• Collaborating with other global study team members, reporting to them on study progress via monthly reports, or ad hoc as required
• Tracking study milestones to guarantee overall delivery
• Preparing the core country documents for successful study initiation, enrolment and maintenance, including the country enrolment plan
• Designing and delivering training to the CRA team to ensure quality site management and adherence to all applicable regulations
• Proactively identifying potential issues and implementing risk-mitigation plans to ensure successful study delivery
• Managing the country study budget
• Training CRAs on all aspects of the study, performing occasional co-monitoring visits and reviewing trip reports
• Delivering expert-level site management, taking full ownership of sites, to include all aspects of site management and monitoring
• Functioning also as a Senior CRA, you will also ensure control of study medication, deliver site-specific training, tracking enrolment at a site level and reviewing essential documents at site

Working consistently and efficiently in this role, no two days are the same as you collaborate with other study team members to bring these life-improving treatments to market.

You are:

Quality-focused, detail-orientated and a key contributor to success.

To enable success in this position you will have:

• Prior experience of leading studies at a country-level, as a Study Manager or Lead CRA
• A proven track record of success in site management and on-site monitoring
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements
• Prior exposure to budgets and feasibility within clinical trials is an advantage
• Degree educated in a life science discipline or international equivalent
• A flexible, open-minded and culturally-aware approach to your work

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.