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Clinical Operations Lead - Belgium
The Clinical Company (company)
Posted on : 22 December 2017
OrganizationSpecialized Biotech Company
Description of the PositionFor a Renown Biotechnology Company we are looking for an Experienced Global Project Manager, who will be in the lead of and driving a team of Clinical Trial Managers and who will be end-accountable to global trials him/herself.
• Supervise the preparation and conduct of the different trials: responsibility for trials running as planned to ensure clean database and within agreed budget and timelines
• In consultation with the Head of Clinical Operations identify the Clinical Trial Lead, ensure that the appointed Clinical Trial Lead is appropriately trained and qualified
• Supervise and guide the Clinical Trial Lead(s) and/or Clinical Trial Assistant(s) including Line Management (including tasks such as but not limited to: performance planning and appraisal, approval of holidays)
• Mentor Clinical Trial Lead(s) and/or Clinical Trial Assistant(s) including providing training on compound specific knowledge
• Provide regular updates on project evolution to the teams (Core team, Clinical Development Team) and to the Head of Clinical Operations
• Perform timely review of the submission documents
• Perform timely review of the core trial specific documents such as but not limited to protocol, protocol amendments, Clinical Trial Responsibility Assignment Form (CTRAF)
• Ensure a proper and timely selection, qualification and oversight of the involved vendors
• First point of contact for Clinical Operations-related questions on the compound
• Strategic and operational decision making with regards to the clinical program and the therapeutic indication
Demands of the Position- Expected educational qualifications: University degree – medical or paramedical (pharmacy, biology, veterinary etc).
- Minimum of 5 years of experience in clinical development (monitoring, local trial management, international trial management).
- Preferably experience in working with Japan and also phase 4 non-interventional studies experience.
- A teamplayer, used to work under internal (sponsor) pressure, working with internal as well external stakeholders.
- Having oversight but also able to hands-on manage a trial.
- Conflict handling, problem solving and innovation.
- Being accountable: exercising judgment/ impact of decisions/ consequence of error.
- Able to manage multiple and varied tasks and prioritize workload with attention to detail.
- Good knowledge of English.
- Excellent knowledge of ICH GCP and European Directives, FDA guidelines, applicable SOPs and guidelines regarding the development of new chemical entities and the conduct of clinical trials.
- Contribute to the development and improvement of departmental procedures, processes and templates.