Japanese Speaking Clinical Study Manager

2 weeks ago

London, United Kingdom Hays Full time

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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