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Clinical Research Scientist-Oncology  /  外資系製薬企業

ジョブNo.NJB1063654
職種 Clinical Research Scientist-Oncology
社名 外資系製薬企業
業務内容 <Purposes of the job are>
・To facilitate/support planning and execution of Amgen 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 visit
-Relationship issue management visit (Apology visit)
-IRB support visit
-Scientific interaction visit
・Act as an interface between study team (RCTM) and AABP 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
・Support Affiliate Medical Directors/Sr. Medical Advisors in developing responses to queries from regulatory agencies
・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
求める経験 <Basic Qualifications>
・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)

<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
語学力 英語力:中級
勤務地
東京都
年収 800万円 - 1200万円
雇用形態 正社員(期間の定めなし)

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