Clinical Study Manager

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Position : Clinical Study Manager

Salary : 13-15 Million Yen

JobRef : 1

Date : 21 January 2012

Minimum language requirements :

English : Advanced
Japanese : Native

Location : Tokyo


Document work and Site management operations
To prepare drafts of the following documents and complete them after reviewing of CPM.
- To prepare a protocol (including protocol synopsis) and a draft of informed consent form and revise them in consultation with CPM and the other related divisions as necessary.
- To prepare drafts of documents on clinical matters to be submitted to the regulatory authority  (PMDA consultation material, etc.)
- To prepare a draft of reply to PMDA inquiries on clinical matters.
- To prepare materials for Pre-analysis review and medical review in cooperation with CPM and Japan CRA Lead.
- To attend GCP inspection, correspond to questions from the regulatory authority, and prepare a draft of replay to inquiries items.
- In cooperation with CPM, to correspond to In-house and On-Site Audit.
- To support Data review meeting or Medical Review meeting.
- In cooperation with Development Support function, to establish and maintain the Trial Master File (TMF) of the concerned project.

To lead preparation of the following documents or review them.
- To coach CRA for remarks from IRB as necessary.
- To coach CRA for the documents to be submitted to the study site as necessary.
- To review clinical study reports(CSRs), investigational brochure(IB), statistical analysis plans(SAP), and the other clinical-study-related documents.

Data review
- To review data at Data review meeting and Medical Review meeting.
- To understand contents of academic articles and CSRs in the assigned field.


- Over 7 years relevant experience in clinical development function, including team leadership
- Experience managing in-house and/or outsourced Phase II or III multi-centre clinical studies from study start-up to study report completion
- Possession of strong technical background in biopharmaceutical research and a thorough understanding of good clinical practice and the regulatory / development process.
- Proficiency in the Microsoft office suite
  -- GCP and current regulatory environment
  -- Medical knowledge and research expertise
  -- Key interfacing areas (e.g. clinical trial supplies, data management, statistics…)

- Ability to plan development strategies
- Foresight and discretion
- Understanding medical/pharmaceutical knowledge in the assigned field and properties of the project.
- Understanding guidelines for the assigned project and involved clinical studies and notifications from the regulatory authority.
- Problem-solving skill: ability to perceive the nature of the problem and solve it appropriately and promptly.
- Negotiation skill
- Global sense: understanding and appropriate correspondence to the Global development process.
- Ability to manage the project
- Coaching skill
- Leadership skill

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