Clinical Study Manager

PrintPrint | ApplyApply | BookmarkBookmark

Position : Clinical Study Manager

Salary : 13-15 Million Yen

JobRef : 1

Date : 21 January 2012

Minimum language requirements :

English : Advanced
Japanese : Native

Location : Tokyo


Responsibilities:

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.

Requirements:

- 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
 

Apply For This Job









Authorized formats : TXT, RTF, PDF and DOCs.

By submitting your resume you indicate your consent for Highland Consulting to process your personal details in relation to highland job vacancies.

All Perm Temp

All Any Keyword