PROTOCOL MANAGER, Medical Data Operations (MDO)の求人情報なら転職エージェントJAC

求人情報

PROTOCOL MANAGER, Medical Data Operations (MDO)

  • 転勤なし
  • 週休二日制
  • 外資
求人番号

NJB1018364

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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-メディカルデータマネジメント

雇用形態 正社員(期間の定めなし)
勤務地 東京都
仕事内容

・A World Wide Medical Data Operations Protocol Manager (PM) will provide end-to-end management of Non-Regulatory Data Generation (NRDG) research.

・The position will focus on Japan-Specific projects

・The PM will provide operational expertise to support programs across brands and will focus on studies including late stage interventional research, Investigator Sponsored Research (ISR), Expanded Patient Access (EPA) & other study types. .Protocol managers act as a matrix leader for the Study Management Team and are accountable for the timely execution of NRDG.

・Manages complex and varied study types across a matrix organization.

・Uses clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality, timelines and budget are managed according to expectations.

・Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution.

・Proactively analyzes and drives efficient problem solving within team’s control.

・Applies critical thinking to manage complex issues.

・Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.

・Manages clinical components of vendor selection and acts as a central point of contact for communication between the team and the external partners (e.g., CRO, networks, alliance partners etc.).

・Allows vendors autonomy in managing their assignments, while holding them accountable for deliverables. Ensures that tasks assigned to vendors are not duplicated by internal protocol/program team members.

・Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables.

・Creates synergy with stakeholders and develops strong alliances with the Medical Monitor/Study Director, Operations Lead, and other team members. Effectively leverages network of internal and external contacts.


■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

・Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.

・Strong understanding of GCPs, ICH and regulatory guidelines as they apply to protocol management and program strategy.

・Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.

・Minimum education BA/BS.

Prefer individual with:

・strong science background

・minimum of 5 years of demonstrated complex trial management experience in the pharmaceutical or CRO industry

・excellent English speaking & writing skills


■職種未経験者:不可

年収 800万円 - 1200万円
語学力
英語力: 
中級

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