R&D Study Operation General

2ヶ月前

Tokyo, Tokyo MSD

Job Description
クリニカルリサーチマネージャーとしての募集となりますが、入社後数年の経験の後、ご本人のキャリア志向も踏まえて、将来は柔軟に広く社内の様々な部署で活躍していくことも可能となります。

【臨床試験におけるオペレーション業務のリーダー】

米国本社カウンターパートと協力し、試験全般のオペレーション業務における日本国内メンバーのリーダー役を担う

  • 試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする
  • チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる
  • 試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う
  • CRA(CRO含む)の相談窓口として、施設レベルの課題を解決する
  • 試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する

資格要件

・TOEIC800点以上、英検準1級など

・海外本社とコミュニケーションが可能な英語力

・CRM、Study Manager 等のご経験3年以上、または、CROで Project Leader 等の経験3年以上

・ネイティブレベルの日本語力

Required Skills
Accountability, Accountability, Clinical Data Management, Clinical Immunology, Clinical Medicine, Clinical Pharmacy, Clinical Research, Clinical Study Protocols, Clinical Trial Management, Clinical Trials Operations, Drug Development, Ethical Compliance, Ethical Standards, Exercises Judgment, ICH GCP Guidelines, Japanese Language, Liability Insurance, Management Process, Medical Research, Medical Virology, New Technology Integration, Pharmacogenetics, Protocol Development, R&D Engineering, Regulatory Requirements {+ 5 more}

Preferred Skills
Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid

Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
03/31/2026

  • A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R373948

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