For the moment we have several junior positions within the Pharmaceutical Industry.
Do you have a Bachelor, Master or PhD degree in a paramedical area, biomedical or pharmaceutical sciences?
Are you fluent in English and do you have good knowledge of Dutch and/or French?
Are you meticulous, quality-oriented and possess good communication skills?
Then don’t hesitate and find out more about your career possibilities in the Life Sciences!
As a Junior Clinical Research Professional you are part of a clinical trial team and are responsible for the smooth execution of the clinical trial process. You have a wide variety of tasks and responsibilities.
We currently have several opportunities to start your career in Clinical Research:
Data Management/ Database Validation
- Review of electronic case report forms (eCRF’s)
- Check clinical databases on inconsistent, missing and incorrect data
- Generate queries towards the sites in order to get the data clean
- Review functional specifications for database-tools
- Create test steps and validation documents for User Acceptance Testing
- Coordinate all trial and sponsor related trainings and oversee that training programs are followed and documented
- Organize User Acceptance Testing
- Communications with all involved parties
Clinical Trial Assistant
- Follow-up on clinical trial administration, meeting coordination, minute taking, travel arrangements, faxing, copying and mailing
- Review of study documents for completeness, consistency and accuracy
- Completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project study plan
- Liaison with study sites and establishment of good communication lines with various departments
Quality Assurance Assistant
- Administrative support (prepare meetings, correspondence, archiving, ...)
- Support to QA Manager, Qualified Person and Quality Assurance Officer
- Preparation of releases and maintain the overview of all releases
- Support in the repackaging process
- To handle the reference standard request from the authorities
- To give support in the artwork process
- Support in the receipt of scientific questions, adverse events and complaints (backup)
- Support in the management of returned products
- Temperature management (data loggers used during transport)
- Quarterly RIZIV reporting on sequential labeling.
- Archiving of release samples, artworks,…
Drug Safety Officer
- Reviewing, assessing and processing safety data for phase I, II & III clinical trials and marketed products
- Maintaining information about all SAEs/ADRs in a secure location, in accordance with local regulations
- Tracking of regulatory guidelines and directives related to Medical Affairs department activities
- Maintaining a ‘list of Authorities and other official bodies’ to whom SAEs/ADRs should be reported, as well as corresponding reporting procedures
- Review of listings, concomitant therapy, line listings, clinical trial protocols, …
- Report writing: narratives, DSURs, PSURs, product-related expert reports, ISSs, Clinical Expert Statements/Clinical overviews for registration renewal purpose, involvement in the writing of the safety section of the IB, SDEA, SPP,…
- Direct reports, backup and internal/external communication
- Bachelor in the paramedical area, Bachelor Medical Management Assistant, Master Biomedical or Pharmaceutical Sciences, Master in Medicine, PhD in a scientific field …
- Fluent in English, good knowledge of Dutch and/or French
- Eye for detail, quality-oriented and well-organized
- Good communication skills, team-player
- Stress resistant
- Experience is a plus
+32 15 21 11 04