... the needs and clinical differentiation strategy. • Provides clinical medical guidance to the Clinical Study Teams to ensure alignment of clinical trials conduct and planning in line ... (when applicable) key clinical trial documents (e.g., protocol, SAP, ...
... compliance approach to ensure our clinical trials will be delivered to the ... European cluster, carrying out the clinical trials, consisting of Local Trial Managers (LTM), Site Managers (SM) and Clinical Trial Assistants (CTA).brYou will be part ...
... Committees. Data review for ongoing trials including blinded safety data review. Is a member of the Clinical Study Team EducationBachelor’s degree in ...
... . Review and analyze data from clinical trials, post-marketing and other relevant ... serious adverse event reports from clinical trials or post-marketing for completeness, ...
... Committees. Data review for ongoing trials including blinded safety data review. Is a member of the Clinical Study Team EducationBachelor’s degree in ...
... , health authority briefing packages, and clinical trial operational documents (eg, protocols, lay ... content expert to regulatory and clinical development teams, including trial and project teams. Education & Experience ...
... Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, ... international reference pricing) Knowledge of clinical trial designs; sound understanding of clinical development & life cycle Fluency in ...
... ) asset leads to support the clinical development and value creation of ... stakeholders such as Medical Affairs, Clinical Development, Biostats, etc. Keeping up- ... challenges of applying these alongside clinical studies in drug development, and ...
... maintain a Quality System for Clinical Trial activities, aligning with the relevant ... outsourced QA activities applicable to clinical trials. Stay updated with current regulations, ...
... protocol, external internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, ... teams to optimize study-specific clinical trial processes. May participate in process ...