职位描述

职位描述： Job descriptionClinical Science ManagerYour challengeYour challenges are to use your clinical research skills to develop and deliver clinical evidence to internal & external stakeholders to further innovation & optimize product life-cycle with flawless execution.Your responsibilitiesAs an Clinical Science Manager you are responsible for:General SummaryThe purpose of the position is to strategically provide clinical and medical supervision and support business activities and internal/external customers.Responsibility?To draft or partner with BIU stakeholders to prepare the clinical evaluation report (CER) to support product registration.?To provide strategic clinical support to the clinical operation team on the medical activities relating to the conduct of a trial, e.g, protocol preparation, study report writing and publication.?Medical Governance: To ensure Health Care Compliance on promotional material in accordance with company SOP and related working procedure. To ensure the contents and claim in following parts of IFU, including indication, contraindication, clinical trial related contents, etc. are accurate, fair and objective.?To provide scientific and medical information to internal and external customers, including unsolicited requests from healthcare professionals, to ensure clinically appropriate use of company products.?Safety vigilance: to work with other stakeholders as a team to provide medical assessment for serious adverse event of pre-approval study.?To provide clinical development strategy to support business team on product and/or procedure management for related therapeutic area, in terms of evidence generation strategy, evidence publication and dissemination, and other related activities.?To develop an understanding SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation, if applicable.Your teamYou will report directly into the Director, Clinical & Scientific Affairs-China. Clinical & Scientific Affairs China team is part of global clinical affairs team, work closely with Greater China Q&R team to support the China product registration via generating the clinical evidence. You will have close interaction with Regulatory affairs, Quality Affairs, Business team (marketing) as well as key opinion leaders and investigators.Our offerWe offer you the opportunity to work as clinical science manager on A-brand big equipment medical device company.We are looking for?Master’s degree & above, clinical medicine or life science preferred.?Minimum of 4 years’ experience in clinical develop experience, medical science experience or product develop experience.?Industry experience in medical affairs in medical device or pharmaceutical company or clinical operation would be preferred.?Be able to collaborate effectively with the Clinical Operations team, cross-functional team members, and external partners?Good communicate skills in English, both orally and in writing?Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner?People management experience is a plus 职能类别： 临床研究员

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