【Role and Responsibility】
・ Oversee the delivery to plan of studies performed by external partners (CROs, vendors and Site) and
monitoring progress by identifying risk and solve operational issues.
・ Lead and manage all activities related to site management and monitoring with agreed timelines, budget and company standard quality.
・ Plan and deliver site selection/ patient recruitment strategy
・ Ensure the quality of clinical study data by raising queries and deviation and resolve issues in a timely
・ Develop and manage risk mitigation plans and contingency plans to execute CRO/site management
・ Lead activities associated with external/internal audits in corporation with Global QA and contribute to regulatory inspection in the area of assigned projects
・ Ensure that all study documents are ready for final archiving and ensure completion of Trial Master File.
・ Ensure translation into Japanese study document such as protocol, ICF
・ Escalate issues related to study management and contribution to resolve
・ Coordinate with global clinical team and manage progress and quality of the clinical studies.
・ Communication and negotiation with business partners (CRO, Contract Lab, etc.) and coordination with internal cross functional team and KOLs.
【Qualification】 Mandatory ・ University degree (or equivalent), preferably in medical or biological sciences or discipline associate with clinical research. Advance degree is preferred ・ At least 6 years experiences from within the pharmaceutical industry or similar organization ・ Good experience of clinical development/drug development process in various phases of development and therapy areas ・ Extensive knowledge of clinical operations, project management tools and processes Nice to have ・ CNS (stroke etc) area experience ・ Global management and negotiation skill preferable 【Skillset】 mandatory ・ Developing and harmonizing team members ・ Influencing and partnership management ・ Business English TOEIC over 700 reading, listening, writhing skill ・ Native level Japanese