Clinical Development Manager 上海

月薪：

该公司所有职位
  • 无工作经验
  • 招2人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 免费班车
  • 弹性工作
  • 绩效奖金
  • 年终奖金

职位描述

职位描述： Description:Lead and manage a cross clinical delivery sub team to operationally deliver defined clinical studies /GMD or clinical project activities to time, cost and appropriate quality. Global Career Level-EAccountabilities/Responsibilities:?Lead and manage a cross clinical delivery sub team to operationally deliver defined clinical studies /GMD or clinical project activities to time, cost and appropriate quality.?Lead the operational delivery of clinical studies, via a team of contributing experts from the study specification to the final clinical study report and archived master file.?Provide input into study feasibility and study specifications, and produce essential documents including the authoring of clinical study protocols across both interventional and non interventional studies.?When working across studies or project work package ensures consistency across the development program.?The CDM may be asked to take up a direct leadership role for a large project work package (such as project managing delivery of a national payer evidence dossier).?To be the interface to partners and oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues.?Responsible for ensuring compliance by clinical delivery sub team with mandatory governance controls such as (Delegation of Authority, Sarbanes Oxley Act, Study attestations, Letter of Assurance and Clinical Trial Disclosure).?Lead the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD).?Lead/contribute to clinical submission assembly, regulatory response and payer evidence teams and contributes to advisory board and steering committee meetings.?Management of changes to project scope and costs (including CRO and other vendors change orders) and reporting project status by participating in project planning and control activities and generation of status reports as required.?Accountable for agreeing with the project team and functions the most efficient procedures to support delivery by taking the project situation and compliance requirements into account. This includes ensuring sufficient appropriate training on AZ processes, SOPs, standards and templates is provided to external partners.?Where appropriate, to apply lean sigma and change management techniques to work packages and in continuous improvement projects.Minimum experience–Education and Experience?University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.?At least 5 years experience from within the pharmaceutical industry or similar organization or academic experience.?Extensive knowledge of clinical operations, project management tools and processes?Good experience of clinical development / drug development process in various phases of development and therapy areas.?Project management certification is desirable but not mandatory.?Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory.?Evidence of developing partnering skills?Ability to learn?Exhibit AZ Leadership Capabilities at level 2 Drives Accountability, Works Collaboratively, and Strategic Leadership,?Exhibits AZ core Capabilities, Influencing, Financial/Fiscal Awareness and Supplier/Partnership ManagementPreferred experience/requirementsNot applicable 职能类别： 生物工程/生物制药

联系方式

浦东新区哈雷路898号

公司信息

阿斯利康是一家以研发为核心的生物制药企业。 通过优质的药物为医药带来意义深远的改变是我们的使命。为了服务患者未被满足的医疗需求，我们坚持对卓越科研实力的不断追求。 我们的专长涵盖药物的整个生命周期，在小分子和生物制剂领域都有所实力。通过运用这些领域的实力，我们寻找包括单一疗法和组合疗法在内的不同方式应对未被满足的医疗需求。 AstraZeneca is a global biopharmaceutical company with research and development at its core. Our mission is to make a meaningful difference to healthcare through great medicines. This is founded on the pursuit of scientific excellence that addresses unmet patient need. Our expertise spans the entire life-cycle of a medicine and we have capabilities in both small molecules and biologics. This allows us to search for solutions to unmet medical needs using both modalities, individually or in combination.

上海相关职位

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企业入驻日期： 2017-11-09

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