Clinical Research Physician(Hematology)
爱恩康临床医学研究(北京)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-10-21
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:3-4万/月
- 职位类别:生物工程/生物制药 医药技术研发人员
职位描述
Basic Function:
Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The CRP participates in development of Clinical Trial Application, protocol development, study execution for the assigned molecule(s)/indication(s) and NDA filing. The CRP is an execution position and, as such, working together with Medical Monitor (MM) developing their knowledge of clinical studies and the pharma/biotech industry.
Primary Responsibilities include:
1. Cross-Functional Team Membership
· Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the MM and SMT to enable effective and efficient CD plan execution
· As requested, supports the Clinical Sub Team (CST) lead and overall team with training new SMT members
2. Clinical Development Plan Implementation
· Provides clinical support across all relevant studies and programs:
o Assistant MM for clinical science related working, including but not limited as follows
-Participates in ongoing SMT/CST and relevant sub-team meetings
-Designs and develops clinical studies for review and discussion with other CST members
-Participates in investigator and other external presentations, meetings and other communications
-May support clinical operations, clinical research organizations (CROs), etc. by assisting MM for questions, other communications, and interactions
-Conducts ongoing data review of medical/safety data for assigned studies
-Supports, as needed, completion of interim study reporting and DBL for final reporting
-Works with other SMT/CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
· Develops presentations for other SMT/CST members
· Completes other special projects, as and when assigned, or otherwise requested
· Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
Qualification and Experience:
· PhD or M.D. with basic medical knowledge or relevant working experience
· Some experience working as clinical scientist in industry, hematology experience is a plus
· Some experience working with the principles and techniques for data monitoring
· Understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)
· Outstanding attention-to-detail
· Has working knowledge of the multi-disciplinary functions involved in a drug development process, e.g. clinical operations, biostatistics, data management, etc.
· Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
· Works well within teams and is effective in collaborating with others internally
公司介绍
联系方式
- Email:sarah.ma@docsglobal.com
- 公司地址:北京市东城区北三环东路36号环球贸易中心 (邮编:100013)
- 电话:18810965020