Global Pharma/Biotech has a unique role for an experienced Japanese Speaking Study Manager to remotely oversee and manage clinical trials conducted from their Japan office. These are general local post-marketing studies in Japan, primarily conducted in Japanese, but also involve collaboration with English-speaking cross-functional colleagues. Business-level Japanese is essential you will also need to work hours to accommodate the time zone differences between the UK and Japan You would be accountable for day-to-day Global Study Operations study execution and related deliverables and is the primary point of contact for a studies. Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the study team, vendors and CRO, as well as collaborating with cross-functional representatives to execute on study deliverables. Responsible for managing early-stage, late-stage, or post approval studies. Engage and collaborate with cross functional team members to drive study activities and is responsible for facilitating and leading Study Execution Team (SET) activities and meetings Technical • Data Analysis and Interpretation • Study Management and Execution • Compliance and Quality • Drug Development and Study Design • Product and Therapeutic Area Knowledge Responsibilities include but are not limited to: • Overall study execution oversight • Provide leadership, guidance, and direction to staff assigned to studies • Lead cross-functional Study Execution Team (SET) meetings • Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans • Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner • Provide regular study quality and progress updates to key stakeholders as needed • Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate • Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program • Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth • Other responsibilities Include: o Contribute to the Study protocol and Informed Consent Form (ICF) development o Management of GSO Study Timelines o Management of CRO and Vendors o Management of Study Lifecycle (start-up, enrollment, maintenance and close-out) o Oversight of Drug / Investigational Product (IP) process o Management of Study Budget o Oversight of Feasibility, Recruitment and Enrollment o Oversight of Study Outcome and Data Deliverables • Lead or participate in program or study-specific projects that have a wider impact • Collaborate with study managers/cross-functional team members to implement department process change and efficiencies This is maternity leave cover, 12 month contract, hybrid role, Please send CV,