Clinical Research Physician, Global Rare Diseases

25 ago - Italia
Chiesi Farmaceutici

Clinical Research Physician, Global Rare Diseases
Department: GRD Clinical Development
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Location: Europe (flexible) – remote or hybrid
Support the clinical team in relevant medical and scientific aspects of the assigned global clinical studies within the global clinical development program
Contribute to the risk/vantaggi assessment of the ongoing clinical trials assigned
May act as the primary medical monitor for an assigned clinical study
Contribute to the production of the Common Technical Document, in terms of validation of scientific documents relevant to the assigned clinical study (e.g., study protocol, investigator’s brochure, clinical study reports) and represent the company in front of health authorities, partners and institutions
Develop and enhance the management of the clinical trials, working in collaboration with the Clinical Program Leader and other relevant roles and ensure medical and scientific validity of the assigned clinical studies in terms of design,



conduct and interpretation
Acting as a member of the program meetings and/or Clinical Study Team, to support the design, conduct, analysis and data interpretation of assigned clinical studies, including the preparation of key relevant clinical documentation in accordance with the Clinical Development Plan and agreed timelines
Conducting medical and scientific review on the data of the ongoing and completed clinical trial data with appropriate oversight
Supporting the Clinical Program Leader in interactions with internal and external stakeholders, acting as the subject matter expert in the assigned product(s) and relevant disease(s) area, and maintaining and enhancing knowledge in relevant technical or therapeutic areas and in global regulations/guidelines
Identifying potential trends and supporting internal decision making, securing timely publication of clinical data according to the agreed publication plan
Ensuring

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