Clinical Research and Development Lead (BB-5DB42)

Trouvé dans: Xpatjobs BE

Are YOU energized by an opportunity to accelerate and deliver a clinical data strategy that drives the opportunity to protect people from infectious diseases? If so, this Clinical Research and Development Lead role could be an exciting opportunity to explore.As a Clinical Research and Development Lead , you will participate to Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK Vaccines process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK Vaccines standard operating procedures (SOP).This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Participate in Clinical Development activities for a study or a number of studies within a specific program or group of related programs. Design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Reporting full accountability to Clinical and Epidemiology Research & Development Project Lead.Bear primary responsibility and accountability for scientific, medical quality, medical/legal and human safety aspects and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigators Brochure and the Clinical Study Report. Supervise the study conduct and serve as the accountable for the overall delivery of the clinical trial, analyze and interpret the results as a subject matter expert and assure that results meet the highest standards of quality and ethical conduct. Serve as a scientific and management reference for the project (internally/externally) Reporting point of full accountability for study data quality and integrity for the entire duration of the study (feasibility & main study) from source through to submission, publication and archiving.As a member of the Clinical Project Team, always actively as a core member of the clinical project team and contribute to achievement of team objectives. Actively participate in preparing the clinical portion of the regulatory files and the registration process, including labellingCollect scientific information and review GSK Vaccines project related documents and publications.Why YOU?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:MD specialized in the field of infectious diseases, internal medicine, pediatrics, obstetrics and gynecology, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset.Minimum 3-year experience into Clinical Research departmentExcellent knowledge of spoken and written English. Understanding of GCP and ICH guidelines; experience working with Regulatory functions a plus.Ability to work well within a matrix environment, balance priorities, and independently handle multiple tasks through good planning, project administration, organization skills.Ability to critically analyze information, identify strengths and weaknesses of approaches and proactively develop remedial actions to mitigate risks.Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.Knowledge and understanding of vaccines, clinical research, and biomedical research regulation Ability to translate scientific skills in the field of vaccines and clinical research into business-driven strategies.Preferred Qualifications:If you have the following characteristics, it would be a plus:Strategic thinking skills and achievement oriented.Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences.License to practice medicine and board and/ or professional certification is an asset.

calendar_todayil y a 15 heures


location_on Rixensart , Walloon Region, Belgique

work GSK

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