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  4. Principal Clinical Research Specialist / Study Manager

投稿日:2021/08/31

(社名非公開)

Principal Clinical Research Specialist / Study Manager

ポジション情報

職種 臨床開発プロジェクトマネジャー
雇用形態 正社員(期間の定め無し)
勤務地 東京都
給与 800万円~1200万円
給与(詳細) 経験・能力・実績および前年収を十分考慮の上決定
職務内容 【Main Mission 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 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 【必須】
〇 Bachelor degree in science field
〇 Knowledge of PML, PAL, GPSP ordinances as well as J-GCP, Ethics guideline, related notices and ISO14155
Statistics
〇 MICROSOFT Exl, PPT, Word, Access
〇 English and Japanese : Business level
〇 More than 5 years of exposures of J-GCP/ISO14155 and GPSP
〇 More than 3 years of experience to manage external suppliers (CRO)
〇 Experience to set up EDC
〇 Project management
〇 More than 3 years successful people management experiences
〇 Good communications skills with respect others
〇 Making difficult decisions, including people issues
〇 Logical thinking
〇 Business Oriented (with Compliance and quality as primary focus)

【歓迎】
〇 PhD or Masters
〇 MD or medical back ground and experiences

企業情報

募集企業 (社名非公開)

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