Clinical Research Scientist_Oncology

Company

◆グローバルランキング15位以内

◆福利厚生充実且つ、離職率も業界水準よりも低め

◆豊富なパイプラインとコンパウンドを持っており、今後もスペシャリティケア領域を中心に増

◆フレキシビリティの高い働き方を推奨し、定年後も再雇用実績あり



Job Description

Purposes of the job are,


To facilitate/support planning and execution of the company 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 the study team and the 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

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)

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