Clinical Project Managerの求人情報なら転職エージェントJAC

求人情報

Clinical Project Manager

  • 転勤なし
  • 週休二日制
  • 外資
求人番号

NJB961053

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会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>
職種

メディカル・バイオ-臨床開発リーダー/臨床開発プロジェクトマネージャー

雇用形態 正社員(期間の定めなし)
勤務地 東京都
仕事内容

■Summary of Job Description:

1. In clinical development strategy, CSPG is responsible, primarily, to create clinical development strategy and package including clinical trial outline. CSPG is also responsible to develop regulatory strategy including PMDA briefing book and outline of CTD for filing, and to develop KOL management in the development phase and/or life-cycle management regarding line-extension.

2. In clinical trial execution, CSPG is, primarily, responsible to execute clinical trials including to develop core documents including protocol, IB, and reporting including CSR review and publications. CSPG is also responsible to manage CRO activities and investigator’ meeting.

■Major Responsibilities:

1. Assist Project Head (PH) for the preparation of the strategy for Clinical Development Plan and associated consultation meetings such as face-to-face advice and prior interview with PMDA (Main stakeholders: LPT/LDEC members)

2. For NDA , prepare CTD and deal with inquiries from the regulatory authorities. (Main stakeholders: Medical Writing Group, Regulatory and Compliance, Medical Division)

3. Perform management of the assigned clinical study as Clinical Project Manager. (Main stakeholders: a person in charge of each unit of Clinical Study Practice organization, defined by SOP).

4. Manage and lead CRO entrusted monitoring activity in the assigned clinical study. (Main stakeholders; CRO)

・Ensure CRO conducts study in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes (Main stakeholders ; CRO)

・Make manuals for conduct clinical study in CRO and confirm CRO executes monitoring activities to follow the manuals and protocol. Also resolve issues caused in the clinical sites. (Main stakeholders ; CRO)

・Confirm CRO implements works appropriately on the check of monitoring reports, CRFs and other documents CRO makes. (Main stakeholders ; CRO)

5. Educate and appropriately support associate CPM and associate).


■休日:完全週休二日制 年末年始

求める経験、能力
年齢制限の理由

■Essential Skills & Abilities:

・At least, 10 years experience in clinical development and experience of one or more NDAs, or equivalent knowledge of clinical development.

・Clinical Development experience for assigned therapeutic area, or equivalent knowledge for the assigned area.

・Experience of completion from start.


■職種未経験者:不可

年収 900万円 - 1300万円
語学力
英語力: 
中級 (TOEIC:750点以上)

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