Study Start Up Specialist

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.

• Accountable for Site Start-Up for assigned clinical
• Serves as site’s primary point of contact for Start-Up, resolving site queries and assisting sites with IRB/IEC submissions.
• Sends Start-Up
• Reviews and approves ICFs pre- and post - ethics committee
• Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Client processes and timelines.
• Assists in resolution of site queries for assigned clinical
• Provides regular updates and escalates site issues to Manager,
• May attend weekly Start-Up meetings with Manager, SSU, Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders as necessary.
• Forecasts and tracks metrics and progress of Site Start-Up for assigned clinical sites, ensuring all sites are greenlit on time per Study Start-Up timelines.
• Ensures metrics in clinical trial management systems are up to date and
• Ensures site essential documents are uploaded to electronic Trial Master File (eTMF) accurately and on time for site greenlight.
• Prepares greenlight packets for assigned clinical
• Performs second review of essential documents and/or ICFs for other members of the Study Start-Up
• Mentors junior Site Start-Up Team
• Manages time on assigned clinical sites across one or more clinical studies and escalates issues to Managers, SSU.
• May prepare and perform IRB/IEC amendment activities, as required.
• Complete training assigned including general training requirements, Operating Procedures (OP), and system and process related training.
• Adhere to OP and processes.
• Contribute to Clinical Contract and Study Start-Up quality, systems, and process initiatives.
• Support study start-up managers with diverse tasks as appropriate and as required.

• Minimum of 4 years of relevant clinical trial experience working in Pharma, Biotech or CRO environment.
• Minimum of 2 years of clinical trial or equivalent Start-Up unit Thorough knowledge of clinical Start-Up process and requirements required.
• Knowledge of CFR and ICH/GCP requirements is
• Requires effective organizational and time management
• Able to multi-task under limited direction and on own
• Strong communication and inter-personal
• Highly responsive and proactive, a team
• Oncology clinical research experience,
• Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint
• Proficiency in English written and verbal communication.

#LI-Remote: