お仕事情報

お仕事情報

Clinical Research Scientist Oncology:SS-4029MY

  • 外資系企業
  • 女性が活躍
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-4029MY
募集職種 Clinical Research Scientist Oncology
職務内容 Purposes of the job are,
・To facilitate/support planning and execution of our sponsored clinical studies, ensuring alignment of affiliate Development TA and Development Operations
・To generate documents with high medical/scientific quality relevant to clinical studies and reporting to health authority

Key activities include, Clinical Development
・Ensure alignment of affiliate development strategy, study design and execution between Affiliate Development TA and Affiliate Development Operations/external partners
・Contribute to the design of the protocol, engaging external experts
・Communicate relevant local medical environment
・Assist DFM in identifying qualified investigators/study sites
・Support Clinical Development Operations activities.
・Support CRA in conducting Site Engagement and Site Evaluation visits, and support remote site evaluation and central monitoring set up.
・Develop and execute study-specific Site Relationship Management Plan for investigators to improve company and investigator relationship, including the below activities as required:Enrollment support visitRelationship issue management visit (Apology visit)IRB support visitScientific interaction visit
・Act as an interface between study team (RCTM) and our Project Team
・Coordinate providing scientific/medical content to address IRB/EC/national authority issues.
・Assist Affiliate Development Operations in protocol interpretation
Scientifically review and edit documents relevant to global development and local clinical activities
・Review translated version of documents relevant to global development and local clinical activities
・Author/review/edit assigned part of CTD collaborating with Medical Director/Sr. Medical Advisor and Medical Writer
・Organize advisory board meetings; data monitoring committees and steering/executive committees coordinating contracts, if necessary
・Handle Consultancy Agreements and other Service Agreements with external experts for contracts owned by affiliate Development TA
・BA/BS/BSc
・Three (3) or more years of clinical research experience and/or academic research experience including experience working on clinical trials
・Plus > 2 year experience in study site-monitoring
・Native level Japanese
・Language proficiency in English (business discussions, reading, and writing)
応募要件 <Skills, Knowledge and Experience>
・Proficiency understanding the clinical strategy for products in the relevant therapeutic area (Oncology)
・Extensive knowledge of Good Clinical Practices (GCP), HA regulations and guidelines, and international regulatory requirements/guidelines
・Experience collaborating with external scientists
・Experience conducting clinical trials in the relevant therapeutic area (Oncology)
・Vendor management experience (preferred)
・Project management/project planning experience (preferred)
・Ability to provide scientific expertise to a clinical development program
・Proficiency in anticipating and resolving problems
・Experience writing and presenting clearly on scientific and clinical issues
・Professional collaboration and leadership skills
・Deep understanding of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and Policy
・Existing therapeutic area knowledge (preferred) and demonstrated ability to rapidly develop deep understanding of new therapeutic areas
・Strong customer orientation; science based and marketing minded
・Finance and budgeting experience (preferred)
・Operational excellence: self-management skills, planning, prioritization, objective setting, meeting management, plan execution
・Interpersonal skills: ability to engage with key stakeholders at a professional and clinical level
勤務地 東京
年収 700万円~1200万円
最終学歴 大卒
推奨される資格要件 理系
その他

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