Clinical Research Lead
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.
Roles & Responsibilities of the position:
The Sites Engagement Manager (m/f/d) is responsible for the management of clinical sites including the site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic areas within a region or country. You will also be responsible for the oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends.
- You will be responsible for all activities required at clinical trial sites and by investigators and site staff participating in the client’s trials; including the site identification and qualification, enrollment planning and execution, to database lock and close out
- You will also perform management and issue mitigation, identification and resolution
- The development of strategic institutional/site relationships will be a main focus
- You will develop and implement site risk plans, ensure site and country level inspection readiness at all times, leverage metrics to inform site/country/regional level for their decision making and provide vendor oversight for site monitoring activities at site/country level
- It will be a goal to establish and develop strong professional relationships with clinical investigators
- All in all you will be the communication “bridge” between sites, third party vendors and the client
- You have a Bachelor’s degree or equivalent in a scientific or health-related field
- You also bring first experience in clinical research as well as good GCP knowledge
- Demonstrated leadership behavior, strong communication skills as well as the willingness to travel (50-75%) are also required
- About 4 + years of experience in clinical trial monitoring or similar experience in the industry
- a very good professional knowledge of Dutch and English