南京 [切换城市] 南京招聘南京生物/制药/医疗器械招聘南京生物工程/生物制药招聘

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

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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