Novartisbrasil Seoul Korea, South
3 months ago
4! The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers. With a strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
We are on our journey to reimagine medicine and our team focus on delivering healthcare solution which fit for purpose. We strive to be the best place to work where our associates could be their best self each day and every day to unleash their full potential.
We are looking for individual to join our team who have passion to improve and extend... people’s lives.
Your responsibilities include, but not limited to:
• Closely collaborates with the operations team to ensure clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local operations team. Review and try to resolve local medical issues / questions and, if feasible, support operations team with recruitment/ operational issues that arise during the entire course of the study – if necessary support the discussion of issues to global teams.
• Provides robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed. Provide protocol, risk management plan & disease training as appropriate, and externally at investigator’s meetings or scientific venues to support recruitment and trial awareness.
• Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feedback, etc.) and analysis of the driven environment
• Review country or site-specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to development clinical trials /NIBR PoC studies when translated into the local language, including the patient narrative where appropriate
• Support Ministry of Health interaction (or local Board of Health) as required. Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials and NIBR PoC trials.
• Perform local AE review for development compounds and provide general medical support for safety issues of: Provide medical expertise support to pharmacovigilance activities, Responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed, Follow-up with the Investigator for additional information or clarifications as needed, When vital, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
• May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as CO representative in Regional/Global team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment
• Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations
Seoul South Korea
Clinical Research Medical Advisor Seoul jobs
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