※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
This position is responsible for the successful execution of local, regional, and/or global clinical trials for assigned projects/studies; this includes undertaking adequate planning, obtaining deliverables within agreed timelines and budgets, ensuring high quality, and meeting all of the company's Standard Operating Procedures (SOP) and regulatory requirements. This position leads the Japan Clinical Team (JCT) and interfaces with the corresponding Japan Compound Team (JCoT), various teams in Global Clinical Development Operations (GCDO), the Clinical Development Team (CDT), and Study Sites (if required). The position is also responsible for the alignment of goals with organizational objectives as defined in the Japan Development Plan (JDP). When managing local trials, the JCOL performs the role of a GCDO Trial Leader (GTL) in GCDO. In addition, JCOL takes responsibility for a part of a GCDO Clinical Trial Manager (CTM).
- The study owner and leader of the JCT. The main focus of the assigned study involves trial management supervision, planning, and coordination. Working closely with the JCoT, the JCOL must ensure that the Protocol Design Elements/Protocol is made available to JCO/GCDO on time. As part of the "End to End Process" (E2E), this includes trial set-up, execution, analysis, reporting (which includes trial closure) and vendor set up, as well as post-study activities. Measures study progress against agreed upon timelines and milestones. Regarding the Request for Service (RFS), the JCOL provides operational input for designing and implementing the protocol. Provides key assumptions to RFS when outsourcing needs/vendors.
- Ensures accurate budget management for assigned trials. This includes ensuring that vendors and affiliate budgets are tracking according to plan. Updates are made to account for changes in the scope of the trial. In the case of fully outsourced trials, the JCOL manages and oversees the Contract Research Organization (CRO).
- Drive the preparation of recruitment/contingency plans and implement ad campaigns as required. Ensures that enrollment commitments meet projected enrollments at the clinical trial level, monitors patient recruitment, and ensures timely and accurate documentation, communicating study progress and issue escalation.
- In local trials, create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, site feasibility related documents by collaboration with CTA. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
- Ensures compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparing for and conducting Health Authority inspections and internal QA audits. Ensures that the JCT operates in a constant state of inspection-readiness. Works with Quality Management (QM) liaisons to ensure quality oversight of assigned trials, using all available tools.
- In coordination with the Japan Clinical Program Leader (JCPL), CTA, the SRP(Study responsible Physician)/CL(Clinical Lead) and/or members of the GCDO/CDT, the JCOL is responsible for providing appropriate trial-specific training to the internal/outsourced trial team members and the site study staff. He or she works with the JCOT or JCT members to set up and coordinate Investigator Meetings, where applicable.
- Ensures that deliverables are provided according to the trial plan. Provides updates to all JCT and appropriate JCoT members on the status of deliverables. Ensures that all required reports are generated and made available for real time tracking of the trial status, in accordance with the trial plan.
- Works closely with the JCoT, JCT, various teams in Global Clinical Development Operations (GCDO), the Clinical Development Team (CDT), the Clinical Supplies Unit (CSU), QM, and external vendor groups.Subject Matter Expert-TA drug development knowledge.
- A BS degree or equivalent is required, preferably in the Life Sciences (Biology, Chemistry, Biochemistry, Nursing, or Pharmacy).
- Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO. However, other relevant experiences and skills may be considered by the hiring manager when reviewing a candidate's eligibility.
※Experiences and skills will be considered
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