.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.Our Study Start Up structure represents an integrated, dedicated, seamless team of experts, all striving to minimize cycle times.
This is especially true of our dedicated and passionate Study Start Up Leads.Responsibilities: Lead all aspects of Start Up activities at the regional level to achieve quick and successful activation of sites.Oversee and manage a team of In House CRAs who perform local EC submissions, prepare IP release packs and support sites at a local level.Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned.Provide country-specific study start-up expertise to study start-up team leads and project teams.Create study start-up document templates.Prepare and coordinate submissions to regulatory, ethics, and other bodies.Perform independent quality review of submission packages.Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.Coordinate and create documents and material needed to support SIV.Responsible for the collection of critical documents required for IP release.Attend study team meetings as required, including Kick-Off Meeting.Develop and maintain effective relationships with local, regional, and country authorities.Comply with all department requirements regarding information provision and status updating and reporting.Minimum Requirements: 2 - 4 years of experience required.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