Job Description
Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
This is a hybrid work arrangement that combines working from our Leuven office with the option to work from home.
You will:
* Collaborate with the project team for site activation processes
* Assist in feasibility research and site identification
* Facilitate site agreement and budget negotiations
* Collect site documents for IRB/IEC submission and/or IP-RED process
* Coordinate translation and review of study-specific documents
* Identify and escalate project-specific issues as needed
* Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
* Prepare IP-REDs packages
* Support initial distribution of Investigational Product(s) and clinical study supplies to sites
* Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
* Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets
* Train and coach department staff on startup processes
Qualifications
* College/University degree in Life Sciences or an equivalent combination of education, training and experience
* At least 3 years of full-scope Study Startup experience in Belgium
* Full professional working proficiency in English and Dutch
* Well-developed communication and organizational skills
* Ability to negotiate and build relationships at all levels
Additional Information
We offer:
* Excellent working conditions
* Extensive training and friendly team
* Competitive salary and benefits package
* Opportunities for personal and professional growth
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.