Clinical Trial Leader - Investigator Initiated Studies

Tokyo 23 Wards Permanent ¥8,000,000 - ¥15,000,000 Foreign Multinational
  • Join an Industry Leading Global Pharmaceutical Company
  • Lead Investigator Initiated Studies to Contibute to Evidence Generation

About Our Client

  • World-renowned multinational biopharmaceutical company specialising in Oncology, Cardiovascular and Metabolic Diseases, Respiratory, Inflammation and Autoimmunity, Neuroscience, Infection and Vaccines
  • Ranked within the top 10 pharmaceutical companies globally in terms of annual revenue

Job Description

  • Accountable for the operational oversight of assigned
  • IISs at an operating company level from start-up through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable company Policies and SOPs
  • Acts as the central contact for designated project communications, correspondence and associated documentation for assigned IISs.
  • Maintains communication with the Sponsor-Investigator and staff during all phases of the IIS regarding study progress, issue identification/resolution, contractual matters including payments and
    collection of required documents.
  • Monitors study progress and initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues to IIS team members in support of Medical Affairs/R&D; Study Responsible Physician/Study Responsible Scientist
  • May provide operational input to protocol development, preparation of IIS proposal documents and the Request for Service
  • Ensures that contracts, budgets and payment schedules are prepared in accordance with IIS contract requirements and HCC/HCBI considerations
  • As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared
  • Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and Clinical Program
  • Accountable for drug management (e. g. projections, requests) for assigned IISs. May assist in bulk drug forecasts/ordering for IIS programs
  • For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the Clinical Program Leader and Study Responsible Physician/Study Responsible Scientist
  • Maintains documentation of assigned IIS in TMF and performs periodic review to ensure accuracy and completeness
  • Maintain and updates applicable company systems including, but not limited to, CTMS, TMS, SharePoint, etc.
  • Uses study tools and management reports available to analyze study progress.
  • Develops therapeutic knowledge to support roles and responsibilities.
  • Establishes and maintains excellent working relationships with external working relationships with external
    organizations, in particular investigators, study trial coordinators and other site staff, internal partners, including Medical Affairs and R&D; Therapeutic Areas.
  • Stays in sync with relevant training requirements.
  • Commits to process improvement initiatives and training and mentoring or other IIS team members.
  • Participates in preparing for or conducting internal audits or in case of Health Authority inspections.
  • Ensure quality oversight and support of assigned IISs utilizing available tools.
  • May be delegated to act as a Functional Manager for Flex associates within the CPL s portfolio/program.

The Successful Applicant

  • University degree, preferably in medical or biological sciences or discipline associated with clinical research
  • Experience in pharmaceutical industry or relative 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
  • Knowledge of process improvement methodology
  • Evidence of developing partnering skills
  • Native level Japanese
  • Business level English

What's on Offer

  • Lead and manage clinical operations for Japan R&D
  • Contribute to oncology portfolio of leading global pharmaceutical company
  • Good work/life balance
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type