SMA II

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.

At ICON Biotech Solutions, our culture is centered around support, growth and development and a drive to innovate.

ICON Biotech Solutions offers our Site Management Associate’s the opportunity  to gain a wide range of therapeutic experience and to work within an open and transparent environment with a focus on offering a flexible and adaptable mindset and approach to make our clients needs.

The Role

As a Site Management Associate, you will be the first point of contact for site staff and you will work closely with the study sites to provide remote support and to ensure patient safety and data integrity.

You will work closely with study Clinical Research Associates to ensure they are up to date with the current status of the sites to maximise the impact of monitoring visits performed by the CRA and play a central and key role between Start Up staff, CRA, Site and Central reviewers.

You may also perform Site Management Contacts (SMC) or off site Pre Site Selection visits. Follow up with site staff to address the findings from central analytics review .

Site Management Associates are critical to monitoring the clinical risk on their studies and their goals include:

• Reduce the time it takes to bring new medicines to patients

• Improve the quality of the data collected on clinical trials

• Ensure the study is run in compliance with GCP and that the safety and rights of the study participants are protected

• Maintain the Trial Master File

• Ensure appropriate documentation in place to meet Regulatory Requirements

You will be operating as a key part of a global study team and plays a fundamental role in our clients’ drug development processes.

Our Biotech Solutions Clinical Delivery team is world class and we are proud to offer huge opportunity for career growth and development through our internal training programs and pre established promotion pathways, ongoing mentoring and employee reward and recognition.

The Requirements

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• Prior experience of working in investigator site management, from either a pharmaceutical company or a CRO environment.

• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.

• You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.

• Fluent in English

ICON 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.