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Study Manager, Clinical Operations  /  外資製薬メーカー

ジョブNo.NJB1035922
職種 Study Manager, Clinical Operations
社名 外資製薬メーカー
業務内容 <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 costs.
・Maintenance/updating of data as appropriate in project management tools including CTMS
・Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
-Study Planning and Conduct
・Facilitation of site feasibility/selection processes with use of robust data
・Operational and strategic input into study documents such
……(以下詳細は面談時にご案内します)
求める経験 <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
語学力 英語力:中級
勤務地
東京都
年収 700万円 - 1200万円
雇用形態 正社員(期間の定めなし)

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