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Clinical Operations Lead Gent Belgium,  

The Clinical Company (company)


Posted on : 22 December 2017

Project Description

Organization

Specialized Biotech Company

Description of the Position

For 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.

Terms of Employment

Why The Clinical Company: We provide competitive salaries, comprehensive benefits packages and the support and training available to take the next step in your career and to have the ultimate experience at a specialized Biotechnolog.
Interested in this challenge and want to apply directly?! Please use the apply button below. For more information, feel free to contact Simone Polman at 0031 (0)612 996 359 or simone.polman@theclinicalcompany.com.

Locations

Gent area

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