Japanese Speaking Clinical Study Manager
7 days ago
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,
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Japanese Speaking Clinical Study Manager
2 weeks ago
London, United Kingdom Hays Full timeGlobal 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...
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Japanese Speaking Clinical Study Manager
2 weeks ago
London, United Kingdom Hays Full timeGlobal 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...
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London Area, United Kingdom Hays Full timeGlobal 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...
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