Site Management Associate - Study Start Up

SINGLE SPONSOR, EMBEDDED SITE MANAGEMENT ASSOCIATE - STUDY START UP


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.
We are looking for a homebased Site Management Associate to be work with our sponsor, a global biotechnology company dedicated to revolutionizing cancer care.
This in-house position is responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving ICFs (Informed Consent Forms) for IRB/IEC submissions for assigned clinical sites.
Responsibilities include, but are not limited to:
Accountable for site start-up for assigned clinical sites
Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with IRB/IEC submissions
Sends start-up packets
Reviews and approves ICFs pre- and post-IRB/IEC submission
Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Seagen processes and timelines
Assists in resolution of site queries for assigned clinical sites
Provides regular updates and escalates site issues to SSU Manager
May attend weekly start-up meetings with SSU Manager, PL, 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 SSU timelines
Ensures metrics in clinical trial management systems are up to date and accurate
Ensures site essential documents are uploaded to eTMF accurately and on time for site greenlight
Prepares greenlight packets for assigned clinical sites
Performs second review of essential documents and/or ICFs for other members of the SSU team
Mentors junior SSU Team members
Manages time on assigned clinical sites across one or more clinical studies, and escalates issues to SSU Manager



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:
3 – 5 Years of Pharmaceutical/Biotech Industry experience
Previous start up unit experience
Knowledge of clinical start-up process and requirements
Knowledge of CFR and GCP/ICH requirements
Fluent in Swedish
Effective organizational and time management skills
Able to multi-task under limited direction and on own initiative
Strong communication and inter-personal skills
Highly responsive and proactive, a team player
Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint