Senior Clinical PMS Manager

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Job details

Company overview

We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.

Responsibilities

• Accountable for day to day activities of all aspects of the operational management of local post-marketing studies (PMCT and PMS), including study timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
• Accountable for the oversight of investigator-initiated studies granted by the company, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
• Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
• Develop and monitor study budget and timelines
• Monitor work to ensure quality
• Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
• Contribute to the planning and set-up of a study and provide planning parameters
• Overseeing external providers, Act as an interface between Global Clinical Operations and local organizations (Global Operations)

Requirements

WORK EXPERIENCE:

• At least 5 years of experience in clinical research in a CRO, pharma or biotech company
• Experience of Post-marketing clinical trials or post-marketing studies or investigator-initiated studies.
• Experience in clinical trial planning and conduct
• Thorough knowledge of ICH GCP

JOB-SPECIFIC COMPETENCIES & SKILLS:

• Demonstrated good interpersonal skills
• Demonstrated good written and verbal communication skills
• Demonstrated good presentation skills
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
• Analytical skills, quick perception and good judgement
• Fluency in English (oral and written) plus local language
• Experience in clinical trial planning and conduct
• Thorough knowledge of ICH GCP

Salary

12 - 17 million yen

Location

Tokyo