Study Leader - Pharmaceutical Company

[Company Description]
Pharmaceutical Company

[Responsibilities]

  • 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
  • Oversee the delivery to plan of studies performed through external partners 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
  • Provide input and maintenance of up to date and appropriate quality, project and study plans(including timings and total costs) in agreed systems
  • Lead a work package or manage a clinical study including scope, budget, timelines, risk management and communicate status 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.
  • Ensure translation into Japanese of study documents.
  • 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.

[Requirements]

  • 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
  • Developing partnering
  • Influencing
  • Financial/Fiscal Awareness and Supplier/Partnership Management
  • Business English (achieve common understanding at the context level)
  • Native level Japanese

[Preferred Knowledge, Skills and Abilities]

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

[Employment Type]
Full time

[Salary]
8M~10M JPY
(Experiences and skills will be considered)

[Location]
Osaka

[Work Hours]
フレックスタイム制 (1日の標準労働時間7時間15分)

[Welfare]
社会保険完備、退職金制度(確定拠出年金)、財形貯蓄制度、持株会制度、慶弔見舞金、健康診断、福利厚生倶楽部、ほか

[Holidays]
完全週休2日制(土、日)、祝日、年末年始6日、年間休日121日(2019年実績)
年次有休休暇(初年度12日、2年目より20日)、慶弔・赴任・リフレッシュほか

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Further details about the company and position will be notified at a later date.