StudyPhysician,Manager

面议

江苏省

刷新时间：2022-07-01

职位描述

Technical / Skills Training

Medical expertise in related therapeutic areas
- Good GCP knowledge and deep clinical trial
related knowledge
- Experience of study design and drug
development plan
- Regulatory guidance for the TA
- Experience of medical monitoring, safety
reporting and Risk Management Plan
- Familiar with CSP/CSR content & data
analysis
- Fluent English and Chinese, written and oral.
- Good Presentation & communication skill
- Can work independently as well as a good
team player
- Demonstrate the leadership in the cross
function work and can adjust to the fast speed
work  

Prioritize and focus with attentive to detail and
excellent analytical skill   

  Working Experience

At least 3 years of clinical development
experience (at least as clinical research
physician for 1~2 years) in pharmaceutical
and/or biotech industry or CRO company

  

  Responsibilities ：

  Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing
medical monitoring)
- Co-owners of clinical study delivery (with Clinical Operations and Stats)
- Development documents (IB, protocol and CSR, etc) content owner
- Analysis and interpretation of clinical study results in partnership with Stats, Clinical
Operations and Safety (as well as Clinical Pharmacologist If necessary)
- Forming and running China protocol review committee
- Forming and running advisory board for portfolio projects;
- Be responsible for interacting and communicating with China KOLs for China development
strategy and protocol design
- Liaise with safety physician for program-level assessment of safety information, evaluation
of safety signals, regulatory compliance of safety reporting including updating safety profile
in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.
- Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
- Setting strategic direction for addressing medical issues in regulatory submission and
communication/interaction
- Be a TA clinical science expert and supporting China regulatory filing and registration
- Be a TA clinical science expert and leading discussions with regulatory officials on clinical
science subjects of a given project
- Oversight the delivery of CRO company and related vendors to ensure the study meet the
timeline and ensure the quality
- Interfacing with CRO study teams and study related vendors on clinical sciences matters
- Providing consultation to clinical operation colleagues on protocol design questions and
answering protocol related questions from site investigators &nbs*****>

其他要求

招聘人数：1人
职能类别：医学经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。