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Clinical Scientist, Hematology/Cell Therapy Area

年収:1000万 ~ 1300万

ヘッドハンター案件

部署・役職名 Clinical Scientist, Hematology/Cell Therapy Area
職種
業種
勤務地
仕事内容 The Japan Clinical Development function provides scientific expertise necessary to design and deliver clinical studies and programs.

Position Summary / Objective

・Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
・May serve as Clinical Trial Lead for one or more trials
・May lead or support trial level activities for one or more trials with the necessary supervision
・May co-lead study team meetings in partnership with GDO/RCO protocol manager and collaborate with cross-functional study team members

Position Responsibilities

・Collaborate and liaise with external partners (e.g., KOLs)
・Seek out and enact best practices with instruction
・Provide regular and timely updates to manager/management as requested
・Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
・Conduct literature review
・Submit clinical documents to TMF
・Develop site and CRA training materials and present these at SIVs and Investigator meetings
・Review clinical narratives
・Monitor clinical data for specific trends; provide trends and escalate questions to Japan Clinical Trial Physician
・Develop Data Review Plan in collaboration with Data Management
・Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data
・Management/Programming
・Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, HA, EC, IRB responses and contribute to regulatory submission.)
応募資格

【必須(MUST)】

Degree Requirements

・Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).

Experience Requirements

・Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
・Ability to understand assigned protocol(s) and their requirements
Basic knowledge skills to support program-specific data review and trend identification
・Intermediate medical writing skills and medical terminology
・Basic planning/project management skills (develop short range plans that are realistic and effective)
・2-3 years experience in Industry in a Clinical research or relevant environment

Key Competency Requirements

・Detail-oriented with commitment to quality
・Basic knowledge of disease area, compound, current clinical landscape
・Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
・Intermediate critical thinking and problem-solving skills
・Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
・Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
・A certain level of spoken and written English for business is required
Travel Required

Domestic and International travel may be required.

【歓迎(WANT)】

Preferred:
・Experience of strategic consulting firm
・Experience of investment bank such as equity analyst
・Professional business management certification and/or diploma

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

We recognize the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

私たちは世界中で、深刻な病気の患者さんの生活に影響を与えることに情熱を注いでいます。包摂的な文化の中で個々の才能と多様な視点を適用する力を持ち、情熱、イノベーション、アージェンシー、責任、インクルージョン、インテグリティという共有の価値観が、社員一人ひとりの最高の可能性を引き出しています。

私たちは、職場環境におけるバランスと柔軟性の重要性を認識しています。当社では、従業員が仕事でも私生活でも目標を達成するためのリソースを従業員に提供するために、競争力のあるさまざまなの利益、サービス、プログラムを提供しています。
リモートワーク

「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
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その他

「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日 2022/06/30
求人番号 2256393

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