Clinical Trial Leader - Investigator Initiated Studies
800万円 - 1500万円
Join an Industry Leading Global Pharmaceutical Company
Lead Investigator Initiated Studies to Contibute to Evidence Generation
- 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
- 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.
- 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
- Lead and manage clinical operations for Japan R&D
- Contribute to oncology portfolio of leading global pharmaceutical company
- Good work/life balance