Clinical Study Manager

Proclinical is working with a leading biotechnology company that is seeking a Clinical Study Manager to be based in Belgium on a permanent basis. As Clinical Study Manager you will be part of the clinical team and be responsible for the conduct and the maintenance of clinical trials. Overall, the job of the Clinical Study Manager is to lead studies from the portfolio program of the company, closely working with internal and external third parties. This is an excellent opportunity for ambitious individuals who are willing to grow in the Clinical Research field and work for a rising pharmaceutical company.

Job Responsibilities:

• Implement all the actions required to carry out the clinical study (from Phase 1 to Phase 4) in accordance with ICH-GCP and regulations in force
• Review key clinical documents (Protocol, ICF, CRF, CSR) to ensure completeness and agreement with GDP / GCP rules
• Organize or facilitate the organization of meetings with investigators and/or KOLs. Synthesize the information and make it available to the clinical team
• Collaborate with various departments involved in the study to develop work plans (Data Management Plan, Safety Plan, Monitoring Plan, SAP...)
• Organize or facilitate the organization of clinical team meetings, prepare agendas
• Identify risks and problems, report them to management, propose and implement remedial actions
• Work with management to ensure the selection of the best possible partners
• Ensure that the clinical study complies with all applicable rules and procedures (EAS collection, data collection ...). This could be done directly or via a CRO
• Ensure strict monitoring of the timing / budget of studies and prevent any deviation from them
• Collect or facilitate the consolidation of budget data and maintain budget updates
• Collect, process, organize and archive study materials

Skills and Requirements:

• Scientific Master degree or PhD level in the field of life sciences
• Comprehensive understanding of all steps of a clinical process
• Knowledge of clinical SOP and GCP standards
• Min 5 years of experience in monitoring clinical trials is desired
• Must be able to work in an international environment
• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global and regional environment
• Excellent knowledge of French and English (speak, write and read). Any other language is an asset
• Excellent analytical, problem solving, negotiation and conflict resolution skills
• Well organized, ability to manage time and to work independently

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lewis Davis on +44 203 8718 095 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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