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Clinical Trial Leader - Investigator Initiated Studies

Tokyo 23 Wards

Permanent

¥8,000,000 - ¥15,000,000

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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
Leader
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