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  4. Senior Clinical Research Specialist / Study manager (CVG CLINICAL CRHF/AFS)

投稿日:2021/09/16

(社名非公開)

Senior Clinical Research Specialist / Study manager (CVG CLINICAL CRHF/AFS)

ポジション情報

職種 臨床企画
雇用形態 正社員(期間の定め無し)
勤務地 東京都
給与 600万円~800万円
給与(詳細) 経験により優遇
職務内容 【MAIN PURPOSE OF JOB】
Pursue clinical trials, post marketing study and surveillance property effectively while aligning regulations and business needs. Collaborate with Global team, suppliers and external key stake holders such as Government, representative of hospitals and physicians.

【MAIN JOB DUTIES / RESPONSIBILITIES】
〇 Develop strategies for trials, study and/or surveillance etc. plans and protocol
〇 Negotiate with PMDA and/or physicians and other key stake holders of conditions and terms of trials, studies and surveillances etc. at the Shonin preparation phase and Shonin evaluation phase
〇 Manage on going and new studies trials, studies and projects.
- Select external suppliers
- Clarify milestones and manage progress
- Make contracts and fix them with sites
- Gather data by EDC or paper CRF and manage them (Using CTMS)
- Make budget plan with milestones, and manage them
- Establish direction of analysis plans and pursuit of analysis
- Build publication plans and publish outcomes if applicable
〇 Make necessary reports to PMDA etc.
〇 Prepare and succeed for audits and self check by internal audit team, external inspection body and PMDA as well as MHLW
〇 Making reports to management and SBU if required

応募資格 【REQUIREMENTS】
〇 Knowledge/Education
- Bachelor degree in science field
- Knowledge of PML, PAL, GPSP ordinances as well as J-GCP, Ethics guideline, related notices and ISO14155
- Statistics
- MICROSOFT Exl, PPT, Word, Access
- English and Japanese : Business level

〇Job Experience
- More than 5 years of exposures of J-GCP/ISO14155 and GPSP
- More than 3 years of experience to manage external suppliers (CRO)
- Experience to set up EDC
- Project management
- More than 3 years successful people management experiences

〇 Skills/Competency Required
- Good communications skills with respect others
- Making difficult decisions, including people issues
- Logical thinking
- Business Oriented (with Compliance and quality as primary focus)

【PREFERENCES】
- PhD or Masters
- MD or medical back ground and experiences

企業情報

募集企業 (社名非公開)

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