Study Leader

Company Overview
オンコロジー領域に強みを持つ、外資製薬メーカー※プロジェクト数は業界TOP3

Job Description
- 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 (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of clinical study protocols and budgeting including authorization and governance of payment).
- Oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) 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.

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 skills
- Influencing
- Financial/Fiscal Awareness and Supplier/Partnership Management

JapanTokyo Map

Name of person in charge of hiring：