Study Manager

2 days ago

London Area, United Kingdom PE Global Full time

PE Global are currently recruiting for a Study Manager – Japanese Speaking - for a contract role with a leading multinational Biotech client based in London – hybrid.

This unique role within GSO requires the Study Manager (SM) to remotely oversee and manage clinical trials conducted from our Japan office. Most of these studies are local post-marketing studies in Japan, primarily conducted in Japanese, but also involve collaboration with English-speaking cross-functional colleagues. As such, The SM role requires proficiency in business-level Japanese and may necessitate adjusted working hours to accommodate the time zone differences between the UK and Japan

For assigned study(ies), the Study Manager (SM) is accountable for day-to-day Global Study Operations study execution and related deliverables and is the primary point of contact within GSO for a study. Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the GSO study team, vendors and CRO, as well as collaborating with cross-functional representatives to execute on study deliverables. The Study Manager may be assigned to and is responsible for managing early-stage, late-stage, or post approval studies. The Study Manager will 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.

Responsibilities

• Overall study execution oversight.

• Provide leadership, guidance, and direction to GSO 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:


• Contribute to the Study protocol and Informed Consent Form (ICF) development.

• Management of GSO Study Timelines.

• Management of CRO and Vendors.

• Management of Study Lifecycle (start-up, enrollment, maintenance and close-out).

• Oversight of Drug / Investigational Product (IP) process.

• Management of Study Budget.

• Oversight of Feasibility, Recruitment and Enrollment.

• 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.

Requirements

• Fluent in Japanese

• 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO.

• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).

• Data Analysis and Interpretation.

• Study Management and Execution.

• Leadership

• Agility & Proactivity

• Communication & Collaboration as well as business Japanese.

Interested candidates should submit an updated CV.


Please click the link below to apply or, alternatively, send an up to date CV to veronica@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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