长沙招聘

JOB OUTLINE
To provide medical, clinical and scientific advisory expertise as requested. Prepares or contributes to the preparation of clinical documents, for either internal or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff. Participates in all aspects of Medical and Scientific Services' involvement on assigned trials.

RESPONSIBILITIES
? Provides medical training and support to project team or investigators for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
? Performs review and clarification of trial-related Adverse Events (AEs), if required.
? Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative.
? Performs medical review of Adverse Event coding.
? Acts as Medical Writer on writing projects and performs competently. Takes responsibility for preparation of assigned documents to good standard, working in accordance with SOPs and the customer's requirements.
? Performs medical review of the protocol, Investigative Brochure (IB), and/or Case Report Forms (CRFs) and other study documents if required.
? Performs review of the Clinical Study Report (CSR) and patient narratives.
? Attends and presents medical topics at Investigator Meetings, if required.
? Provides therapeutic area/indication training for the project clinical team.
? Attends Kick-Off meetings, team meetings and client meetings, as needed or requested.
? Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of new projects.
? May be responsible for develop training materials and delivery related trainings to junior staff.
? Support BD team on the proposal development for new projects, provide medical input and meet clients if required.
? May be assigned as the author on SOP for medical science & service.
? Complete other tasks assigned by Line Manager.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? In depth of knowledge on clinical medicine or certain therapeutic area(s).
? Good knowledge of clinical research and applicable regulatory requirements.
? Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer.
? Excellent written and verbal communication skills, in both Chinese.
? Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
? Effective time management skills.
? Ability to manage competing priorities.
? Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? At least Bachelor degree of clinical medicine.
? At least 3 years working experience in hospital to treatment patients, or equivalent combination of education, training and experience.
? At least 2 years experience in clinical research and 1 year experience as medical advisor.
? At least CTE-6 level.

PHYSICAL REQUIREMENTS
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
? Extensive use of keyboard requiring repetitive motion of finger.
? Regular sitting for extended periods of time.
? Occasional travel.

    昆拓信诚医药研发（北京）有限公司是艾昆纬公司投资全资子公司，为美资CRO公司，依托艾昆纬公司全球高标准的质量管理系统和资源，昆拓形成了涵盖所有运营部门的完备标准操作流程（SOP）系统以及质量控制体系。
    昆拓秉承诚信、责任、合作、创新的公司文化，致力于成为中国本土临床研究服务的领跑者，以艾昆纬为依托，用心提供高品质的专业化服务。昆拓具有开放、友好的公司文化氛围，制定了严格的人才培养机制，为员工提供了良好的培训以及职业发展平台。
    人员一经录用，公司将提供富有竞争力的薪酬水平。除去国家规定的五险一金外，公司还给员工提供商业医疗保险和商务旅行保险、年度体检、重大疾病保险及人身意外保障等。