Senior Clinical PMS Manager

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Job details

Company overview

This company is one of the world’s leading pharmaceutical companies.

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