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【R&D】Study Leader, Clinical Operations

Plats Kita-ku, Ōsaka-fu, Japan Jobb-id R-034228 Datum inlagd 08/28/2018

【職務内容 / Job Description

To deliver clinical studies in Japan

  • Manage a cross functional team of clinical experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality including documentations.  
  • Provide input into study start up activities (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of clinical study protocols and budgeting including authorization and governance of payment).
  • 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. 
  • Lead and manage all activities related to site management and monitoring including the following with agreed timelines, agreed budget and company standard quality.
  • Plan and deliver a site selection strategy
  •  Patient recruitment strategy including SMO managements
  •  Lead and manage CRAs including CRO CRAs to deliver clinical study data
  •  Develop and manage risk mitigation plans and contingency plans to execute site managements and monitoring from sites clarification to sites close on time.
  •  Manage the quality of clinical study data including queries and deviations and resolve issues as needed.
  •  Ensure the quality of monitoring visit reports focused on study specific contents.
  •  Lead activities associated with site audits in liaison with Clinical & Pharmacovigilance QA  and contribute to regulatory inspection in the area of site management and monitoring
  •  Escalate issues related to site management and monitoring to an appropriate person and contribute to resolve.
  • Responsible for ensuring timely compliance by clinical delivery sub team with mandatory governance controls (such as Delegation of Authority, Study attestations, Letter of Assurance and Clinical Trial Disclosure). 
  • Provide input and maintenance of 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 a work package or manage a clinical study including scope, budget, timelines, risk management and communicate status (e.g. via generation of reports) and make a consultation with relevant function as required.
  • Provide input along 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 that ensuring sufficient appropriate training on AZ processes, SOPs, standards and templates is provided to external partners.
  • Ensure translation into Japanese of study documents such as CSP and MICF.
  • Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
  • Manage the study delivery related activities associated with regulatory inspections/audits in liaison with Quality Assurance and other relevant parties. 
  • May be assigned responsibility for project management and leadership of non-drug project work including applying lean sigma and change management techniques.

【応募資格(経験、資格等)/ Qualification (Experience & Skill etc)

◆◆経験 / Experience◆◆

<必須 / Mandatory

  • 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

<歓迎 / Nice to have

  • Oncology experience
  • Knowledge of process improvement methodology such as Lean Sigma/Change Management

◆◆資格 / License◆◆

<歓迎 / Nice to have

  • Project management certification

◆◆能力 / Skill-set◆◆

<必須 / Mandatory

  • Developing partnering
  • Influencing
  • Financial/Fiscal Awareness and Supplier/Partnership Management

◆◆語学 / Languages◆◆

<必須 / Mandatory

  • Business English (Speaking level 7 or above, achieve common understanding at the context level)
  • Native level Japanese

◆◆勤務地 / Work Location◆◆

  • Osaka or Tokyo

◆◆キャリアレベル / Career Level◆◆

  • D



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.

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