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Clinical Development Manager

Location Shanghai, Shanghai Municipality, China Job ID R-009805 Date posted 22/06/2017


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-E


  • 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 Management

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056679 E CDSM

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.