Do you have experience in start up activities and wish to expand your experience in one of the best Pharmaceutical companies in the world? Don't hesitate and apply now!
Job Description
As a Study Start Up Lead you will be responsible for various critical tasks that are part of the successful delivery of clinical trials in Belgium.
Responsibilities
- You will oversee the study start-up process to ensure timely and efficient site activation and regulatory compliance. This, amongst other tasks includes creation of the country specific ICFs in national languages.
- You will oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination.
- You will identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels within study start up.
- You will collaborate with regional and global counterparts to harmonize systems and improve timelines.
- If needed, you will manage and negotiate budgets and contracts with internal and external stakeholders.
Requirements
- University degree or equivalent; preferably in a medical/science-related field.
- At least 2 years experience in ICFs and/or submissions in EU (depending on your background/skills, your level will be determined).
- Good knowledge of ICH GCP, SOPs/Guidelines and quality standards related to study management.
- Native Dutch or French with very good knowledge of the other language, excellent English.
- Communication: excellent written and verbal communication skills.
- Open mindset to work on different tasks to be able to meet study timelines.
- Eagerness to learn.
- Organizing: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.
- Problem-solving skills.
- Existing right to work in Europe required.
Benefits
- Permanent contract with Oxford Global Resources.
- 0.8 to FTE.
- 2 days per week at the office in Brussels.
Vacancy number: 26747
