Study Startup Specialist II
Study Startup Specialist II
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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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
