Project Leader - Firecrest

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.

The Role:

This role is part of our Firecrest team.

The FIRECREST Site Portal is the industry's number one site portal. It enables centralised role based user management across studies, connecting site and study staff. Built to work the way investigators do, it improves site performance and is versatile enough to host single studies or an enterprise-wide portfolio of studies.

Responsibilities:

• Support and/or be the lead study manager with the administration, coordination and management of study activities, including but not limited to:

• Coordinate the creation and delivery of FIRECREST study portals on time and within budget.

• Liaise with the Sponsor, study team and FIRECREST Production team on a daily basis, to ensure that all study requirements are met.

• Provide demonstrations of FIRECREST functionality to Sponsor and study teams, ensuring optimum utilisation of the platform.

• Coordinate the creation and delivery of FIRECREST study portals on time and within budget.

• Liaise with the Sponsor, study team and FIRECREST Production team on a daily basis, to ensure that all study requirements are met.

• Provide demonstrations of FIRECREST functionality to Sponsor and study teams, ensuring optimum utilisation of the platform.

• Maintaining study project plans and adhering to study commitments and timelines

•  Development of study specific logistics and documentation for review and approval by Sponsor

• Relationship management with the sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel

•  Participate in Sponsor IM’s and SIV’s

•  Project calls, webinars, teleconferences and meetings

•  Scheduling  training, conducting training with subcontracted clinicians;

•  Entry into CRM and review of study CRM reports

•  Pre-visit and post-visit follow-up with clinicians

•  Review of study documentation for accuracy, completeness and turnaround times;  solicit information to support inquiries;

• Filing of study communications Handle, or seek advice in order to handle, sensitive issues effectively

• Other duties as assigned

• Transition into the lead study manager role and assume all responsibilities, if not already leading studies

• Ensure high satisfaction of all stakeholders

• Ensure visits are not missed, documentation is timely, complete and accurate and lab samples are evaluable

• Comply with ICH/GCP, IATA, HIPAA, Data Privacy and other appropriate regulations

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.