For one of its sponsors, ICON is looking for a Clinical Trial Manager.
What is our sponsor involved in?
Our sponsor is an American pharma company mainly active within oncology. But also other therapeutic areas such as vaccines, infectious diseases, diabetes, anesthesia, rheumatism, cardiovascular diseases, ... are covered. The studies are in phase 2 and 3.
Our partner is the largest and most versatile drug company in the Netherlands. For more than 130 years they have been investing in the major medical issues of our time. At their facility in the Netherlands, they develop new biopharmaceutical innovations, conduct research, manufacture and package. Their medicines are exported to more than 140 countries.
What environment will you be working in?
You will join a team of about 40 people (6 trial managers, 23 CRAs, 6 SSU&Regulatory specialists and 4 CTAs).
Our sponsor places great importance on teamwork. One day a week, our team meets in the office. Nice to know: the office in Haarlem has just been renovated! You will be working in a very modern environment.
Your development is our top priority. At your start you will sit together with your line manager every day, this will be reduced as you can work more independently. Often ad hoc meetings are scheduled when you have questions.
In addition, you will have double the number of events you can participate in. ICON itself organizes an event in both summer and winter.
What exactly does your job entail?
In this position you are responsible for end-to-end performance and project management for assigned protocols in the Netherlands. For certain studies, you may be responsible for multiple countries in a cluster.
Your responsibilities include :
- Point of Contact (POC) for assigned protocols and liaison between Country Operations and the clinical trial team (CTT).
- Project management of assigned studies: feasibility, site selection, recruitment, execution, close-out
- Works closely with and supports CRAs as protocol expert
- Review Monitoring Visits Reports and escalate performance issues and training
- Needs to CRA manager (Performs quality control visits as needed)
- Lead local study teams
- Prepares and implements local risk management plan for assigned studies
- Ensures compliance of CTMS, eTMF and other key systems
- Responsible for collaboration with vendors, investigators, other partners
- POC for programmatically outsourced studies for assigned protocols.
- Shares protocol-specific information and best practices between country clusters.
Who are we looking for?
You have a heart for clinical studies, everyone can tell by the drive and enthusiasm you show every day.
You discovered your passion for your profession during your Education in biomedical sciences, nursing, medicine, physical therapy or another related field.
You have several years 5-6 years of work experience in clinical research and work(s) as a CRA. In addition, you have already gained experience in trial management.
You can express yourself well in Dutch and English.
OUR OFFER
Homebased contract, where you are willing to go to Haarlem 1x/week. More is also possible.
Fascinating projects at our sponsor
A lot of variation, many learning moments and especially many new challenges
Coaching by the sponsor AND icon
Focus on work-life balance
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