南京 [切换城市] 南京招聘南京生物/制药/医疗器械招聘南京临床研究员招聘

临床项目经理

上海康德弘翼医学临床研究有限公司

  • 公司规模:500-1000人
  • 公司性质:合资
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2018-03-03
  • 工作地点:上海
  • 工作经验:5-7年经验
  • 语言要求:英语熟练
  • 职位月薪:2-2.5万/月
  • 职位类别:临床研究员  

职位描述

Overall Job Purpose/Function:

The Project Manager is responsible for owning and achieving interim and final contractual deliverables for assigned projects/programs, according to the time, quality/scope and cost constraints.

The PM leads and directs cross-functional teams, understands and manages client expectations/ needs to achieve client satisfaction. The PM proactively identifies, resolves/mitigates and escalates risks and/or issues. The PM adheres to PRA standard procedures and processes.

The senior PM may act as global or lead project manager in international projects. Consequently, the senior PM may provide oversight to other members of the project management group

Principal Accountabilities and Responsibilities:

  • Acts as primary liaison with client:

o Acts as lead contact for regional and or/project matters.

o Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.

o Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.

o Chairs and leads client meetings.

? Leads and directs cross-functional team leaders and third parties/vendors:

o Validates project plan (multi-service plan and communication plan).

o Guides and supports team leads in prioritizing, trouble-shooting and contingency planning.

o Delegates whilst retaining ownership.

o Communicates project specific priorities.

o Liaises with functional leads/managers to optimize performance and utilization of project team members.

? Manages project contractual deliverables:

o Supervises progress via metrics.

o Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).

o Leads presentation of internal project status reviews and is accountable for action item follow up.

o Proactively identifies, resolves/mitigates and escalates risks and/or issues.

? Manages project costs:

o Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis.

o Proactively and timely identifies, negotiates and executes contract modifications for assigned projects, ensuring out of scope activities are approved upfront via a contract modification.

o Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval.

o Ensures control of financial risk to PRA.

o In cooperation with the project analyst, applies efficient management of project pass-through costs and investigators payments to ensure all such costs are recovered in a timely manner, and in advance where ever possible.

o Leads presentation of financial reviews and is accountable for action item follow up.

o Ensures adherence to company SOP, policies and guidelines at the project level.

o Assumes project leadership role in compliance at project level to COMPANY processes and systems such as CTMS,

ART, eTMF, PSR etc., including escalation to relevant functional and operational management.

o Participation and attendance in bid defense process.

o Mentoring of other members of the project management team or functional leads, as required.

o Provides feedback on project team member’s performance to respective line-managers

Requirements for position:

  • Bachelor or above degree with medical/pharmacy or other health-related background;

  • At least 5 years experiences of clinical research in pharmaceuticals or CRO companies, and over 2 years related experiences in project management;

  • Working knowledge of clinical research procedures and companyctices including local regulatory

  • requirements and GCP/ICH Guidelines for the conduct of clinical studies;

  • Strong leadership, organizational, interpersonal and communication skills, with an ability to prioritize and manage work for a team;

  • Ability to supervise and delegate tasks and provide clear instruction to others;

  • Highly self?motivated and proactive with the ability to work independently;

  • Strong problem solving skills with ability to identify potential problems and provide creative solutions to issues surrounding on?time, on?budget and quality delivery;

  • Attention to detail;

  • Able to communicate clearly & accurately in both written & spoken English.


职能类别: 临床研究员

公司介绍

康德弘翼(WuXi Clinical),是药明康德(WuXi AppTec)的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务,包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册,通过严格的质量控制体系和专业团队的丰富经验,帮助创新性,突破性医药产品尽快上市和造福患者。

康德弘翼立足中国,面向世界,以上海总部为中心,辐射全球制药公司、生物技术公司以及医疗器械公司。目前,公司实行中美联合运营,人员规模达850人,覆盖中美两地,全国30多个主要城市,在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系,始终保持着紧密的业务交流,保证了项目能高效、高质地完成。

随着业务能力的不断提升,我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月,药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营,2019年5月,再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace,这让WuXi Clinical的规模再一次得到扩大,进一步完善和增强了我们全球一体化研发服务平台的综合实力,帮助全球创新合作伙伴更好、更快地开发医药产品。

联系方式

  • 公司地址:上海市黄浦区淡水路299号SOHO复兴广场A幢801室 (邮编:200020)