General description

The Global Study Manager is the key point of contact between the central functions and the local actors of the clinical studies and coordinates the operational aspects of a clinical study from start to end, in compliance with ICH GCP guidelines and client’s policies/SOPs

Key responsibilities & accountabilities

• Manage the Studies according to ICH GCP guidelines and CLIENT policies and SOP’s to ensure the quality of the Studies data in order to use them in registration dossiers submissions to regulatory authorities.
• Manage operational/monitoring related issues for the Studies between the central functions and the local actors of the Studies and coordinates the operational aspects of the Studies 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 (Data Management, …) 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...). Sign-off of essential documents  (protocol, CRF, ICF, primary SR, report)
• Propose, organize and lead Studies monitors meetings, to transfer knowledge and Studies specific training in order to ensure the highest quality standards. Assess need for and propose co-monitoring visits in countries or do co-monitoring upon CLIENT’s request.
• Work with Clinical Trial Assistants and/or Global Study Managers involved in the Studies and assure coaching if required by CLIENT. 
• Have the full responsibility for the monitoring of the Studies sites, to ensure compliance with ICH-GCP and CLIENT SOPs, including coaching Global Study Coordinators for monitoring, pre-study, initiation, close-out visits and audits.

Required education & skills

• University degree (or equivalent) in the science field.
• Relevant experience in clinical research, good knowledge ICH-GCP. In depth knowledge of GCP and SOP standards. Basic understanding of pre-clinical drug/vaccine development and good understanding of clinical vaccine development. Experience in monitoring (as CRA – Clinical Research Associate - or CRC – Clinical Research Coordinator - for example) is a definite plus.
• Possess strong presentation and negotiation skills
• Able to effectively express ideas in English, incorporate feedback into deliverables to generate a complete quality output. Knowledge of French and/or Dutch is an asset.
• Report adequately to target audience and management.
• Be open and is able to adapt to cultural differences
• Demonstrate and encourage team spirit