株式会社 ジェイ エイ シー リクルートメント(東京/北関東/横浜/静岡/名古屋/京都/大阪/神戸/中国)

株式会社 ジェイ エイ シー リクルートメント (東京/北関東/横浜/静岡/名古屋/京都/大阪/神戸/中国)

Study Manager, Clinical Operations(血液・腫瘍or免疫・炎症)

求人会社名 : 外資製薬メーカー

求人ID : NJB1035922

  • 外資系
  • 勤務地限定
  • 語学(英語)を生かす
  • 土日祝日休み
  • 年間休日120日以上
  • 駅徒歩5分
仕事内容 <Summary/Scope>
The Study Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, JGCP, Regulatory Authorities’regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross‐functional Japan study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO).
Study manager has full responsibilities for studies led by the Japan Study Team. Responsibilities in the global study is complied with Affiliate Involvement Model (AIM), Job aid and direction given by Global Clinical Trial Manager (CTM).
Responsibilities involve a combination of execution and oversight‐dependent on the sourcing model ‐ to ensure deliverables and may include, but are not limited to, the following:
‐Financial Planning and Management
・Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget
・Takes ownership and accountability for the development/management/reconciliation of overall study budget(s)
・Development/management of vendor scope of work (SOW) per contract, quality, and budget
・Review/approval of vendor invoices and management of accruals and SOW changes
・Review/approval of site invoices and management of site budget
‐Project Management
・Drive study execution
・Oversight of clinical monitoring quality and adherence to established processes and plans
・Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter‐personal influencing skills to make robust data driven decisions
・Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade‐offs of balancing risks with study deliverables and cos…
応募資格 <Skills/Knowledge Required>
・Clinical trial project management skills
・Financial budgeting and forecasting skills
・Leadership / influence management skills
・In depth knowledge of ICH/GCP, JGCP, regulatory guidelines/directives, and drug development and clinical research processes
・Ability to effectively lead a cross‐functional team in a matrix environment
・Time management skills ・ ability to effectively multi‐task and prioritize
・Proven problem solving and decision making skills
・Demonstrated success in using oral and written communication skills to influence, inform, or guide others
・Disease / therapeutic knowledge
・Solid computer skills ・ requirement of MS applications including (but not limited to),Word, Excel
・Study Tools including electronic system skills ・ CTMS / EDC
<Key Leadership Competencies>
・Creates realistic plans that clearly define goals, milestones, responsibilities and results
・Maintains focus on strategic objectives while accomplishing operational goals
・Places a priority on getting results with an emphasis on high quality outcomes
・Holds self and others accountable for accomplishing goals
・Makes timely, data‐driven decisions
・Develops and maintains effective working relationships with people across cultures
・Encourages collaboration across teams, functions, and geographies
・Ensures that conflict is handled constructively so that performance is not impacted
・Displays a willingness to challenge the status quo and take risks
・Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute
・Maintains optimism and composure in times of change, uncertainty, or stress
<PREREQUISITES>
‐Organizational Impact
・Contributes to Japan R&D objectives
・Moderate impact on study team
‐Discretion/Latitude (Level of Independence)
・Requires moderate oversight
・Sets priorities with guidance
・Minimum 2 years experience of the pharmaceutical/medical field
勤務地 東京都
勤務時間 8:30~17:30※詳細はオファー時に通知いたします。
年収・給与 700万円~1200万円
待遇 【通勤交通費】
全額支給
【保険】
労災保険 健康保険 厚生年金 雇用保険
【待遇・福利厚生】
退職金制度(確定拠出年金)、ストックオプション(※但し、ポジションに応じる)
休日・休暇 【年間休日】
120日
【休日】
完全週休二日制
土日、祝日、夏休み(3日)、年末年始(12月29日~1月4日)

雇用区分 正社員(期間の定めなし)

求人会社概要

求人会社名 外資製薬メーカー
概要 求人紹介時にご案内致します。
業種 食品・医薬品・化粧品

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