GlaxoSmithKline Biologicals (GSK Biologicals), la division vaccins du groupe GSK, se définit comme une entreprise mondiale de recherche, de développement et de production de vaccins à la pointe de l’innovation dans la lutte contre les infections et les maladies les plus menaçantes. La Belgique est le quartier général mondial de la division vaccins qui emploie plus de 11000 personnes dans le monde, dont quelques 8000 sont répartis entre trois sites belges : Rixensart, Wavre et Gembloux. Le réseau global de GSK Biologicals, comptant 15 sites de production stratégiquement positionnés à travers le monde, est consacré à la recherche et au développement clinique, aux activités de production, ainsi qu’au contrôle et à l’assurance qualité.

For this Immunotherapeutic(s) program, we are looking for a (m/f):



You are working within the Clinical Operations department and are the global operational primary contact for the studies you manage. Those studies can be of all type: from Phase I to Phase III, standard or non-standard project, collaborative, multi country,…
Your main role is to manage the studies you’re entrusted according to ICH GCP guidelines and GSK policies and SOP’s and to ensure the quality of the study data in order to use them in registration dossiers submissions to regulatory authorities.
In this context, you:
- Act as the reference person for all operational/monitoring related issues for your studies between the central functions and the local actors of the studies and you coordinate the operational aspects of a clinical study from start to end;
- Analyze and evaluate the feasibility and consequences of design proposed in regards to procedures, consult other departments (double blind lots…), other teams (DM, …) and with the countries for the monitoring. Ensure necessary specific user-guide is prepared on time (CRF completion guidelines, manual cleaning guidelines, Investigator laboratory manual...) and you sign-off of essential documents (protocol, CRF, ICF, primary SR, report);
- Propose, organize and lead monitors meeting as well as you assess the need for and propose co-monitoring visits in countries or do co-monitoring upon request;
- Actively participate and represent the Global Study Management function, taking into account the need of peers/other projects, in internal process improvements as well as training on their specific taskforce, including presentations at GSM meeting, workshop, SOP session, Inv/monitors meeting
- empower and coach junior people of your team.


- you hold a Bachelor or a Master degree in sciences;
- You have at least 5 years of experience in International Clinical Trials environment;
- You’re familiar with Oncology therapeutic area;
- You have a good knowledge and understanding of Clinical Study Management roles and activities and a good knowledge of ICH-GCP;
- You have a knowledge of regional organization and a good understanding of Local Operating Countries structures;
- Monitoring experience is an asset;
- You are English fluent, any other language is an asset.


- A challenging job within a highly innovative GSK Bio programme;
- A contribution to high-tech research and development in the field of cancer
- A growing, confident and ambitious business to be a part of driven by science, performance and the pride to ensure a healthier an happier life to patients.