临床研究经理 上海

月薪： 2-3万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴

职位描述

职位描述： Major Responsibilities1 Contribute to efficient clinical research organisation and functioning.2 Contribute to the quality improvement of the study processes and other procedures.3 Ensure compliance with local regulatory requirements and ProMed Procedural Documents, together with the ProMed Quality Manager.4 Manage workload, plans and resource needs.5 Track and deliver agreed budget.6 Handle Study Requests from Clinical Resource Coordination (CRC).7 Ensure clinical and operational feasibility assessment of the Study Design Concept and Clinical Study Protocol is performed in the country.8 Allocate adequate local resources to deliver agreed commitments in global studies.9 Allocate Monitors/ Leaders to ProMed Study Teams.10 Contribute to and approve selection of investigators.11 Approve draft contracts with and payment proposals to external partners, vendors and investigators.12 Ensure patient recruitment strategy is in place.13 Ensure risk assessment is performed and contingency plan is in place.14 Perform regular co-monitoring visits.15 Supervise study performance and pro-actively advice ProMed Leader/Monitor.16 Work in close collaboration with the ProMed Quality Manager in planning of training, internal audits and regulatory inspections.17 Provide information and update the VP of Clinical Research/ Clinical Operations Management about ongoing and planned clinical studies on a regular basis.Competences / Skills1 General education and background2 University degree or equivalent.3 Excellent knowledge of spoken and written English.4 Good ability to learn and to adapt to work with IT systems.Functional Skills1 Excellent knowledge of relevant Procedural Documents.2 Excellent knowledge of international guidelines ICH/GCP.3 Basic knowledge of GMP/GDP.4 Excellent knowledge of relevant local regulations.5 Good medical knowledge in relevant Therapeutic Areas.6 Good understanding of the Drug Development Process.7 Excellent knowledge in Clinical Development.8 Excellent understanding of the Clinical Study Process.9 Good understanding of the Monitoring Process.10 Good understanding of the Clinical Study Drug Handling Process.11 Good understanding of the Data Management Process.Management Skills1 Excellent experience in people management and leadership, including performance appraisal.2 Excellent resource management skills.3 Good experience of financial management skills.4 Good decision-making skills.5 Good change management skills.6 Excellent delegation skills.7 Excellent coaching skills.8 Good conflict management skills.9 Good interviewing skills – responsibility for attracting, developing and retaining personnel.10 Good in handling crisis situations.Other skills1 Excellent project management skills.2 Excellent team building skills also in cross-functional teams.3 Excellent interpersonal skills.4 Good intercultural awareness.5 Excellent strategic and operational organisational skills.6 Excellent analytical skills.7 Excellent influencing skills.8 Excellent negotiation skills.9 Excellent verbal and written communication skills.10 Excellent presentation skills.11 Excellent ability to prioritize and handle multiple tasks.12 Good ability to have attention to details.13 Excellent ability in working according to global standards. 职能类别： 临床研究员

联系方式

银霄路39弄33号

公司信息

铂镁医学临床研究（上海）有限公司注册于上海张江高科技产业园区，是一家为国内外医药界提供新药或仿制药临床开发（Ⅰ-Ⅳ期）和药剂工艺改良的全方位外包服务公司。

上海相关职位

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周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南

企业入驻日期： 2017-11-09

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