R&D Study Operation Oncology CRA at Merck Sharp & Dohme Corp. /Netherlands

Chiyoda, , Japan -

Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

0.0

Posted On

25 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oncology CRA, Clinical Trial Management, Clinical Trials Monitoring, ICH GCP Guidelines, Patient Recruitment, Patient Safety, Protocol Development, Regulatory Compliance, Clinical Data Management, Drug Development, Clinical Investigations, Clinical Sciences, Documentations, English Proficiency, Communication Skills, Microsoft Office

Industry

Pharmaceutical Manufacturing

Description

Job Description 【職務内容】治験責任医師候補及び治験実施医療機関候補の調査治験の依頼及び契約各治験施設での組み入れプランに沿った組み入れ依頼及び組入れ状況の確認治験施設での有害事象情報の収集及び安全性情報の治験施設への伝達必須文書の作成及び授受モニタリング報告書の作成症例報告書のカルテとの照合治験の終了手続き開発品及び競合品の情報収集【必要とする資質】 Oncology CRA経験：4～5年以上医師、CRC等に対するコミュニケ－ション能力社内プロジェクトメンバーの一員として自発的に行動できる積極性及び協調性治験薬概要、治験実施計画書等を理解し説明できるプレゼンテーション能力医学関連全般の基礎知識グローバル研究開発本部の他部門と協調しながら業務を遂行できる能力パワーポイント、ワード、エクセルのコンピュータースキル英語力（TOEIC 730以上：メールでのビジネスが可能なレベル）【望ましい資質】 GCP、社内SOPの知識（異動後に研修あり）担当する治験薬、疾患領域に関する知識（異動後に研修あり）英会話能力（プレゼンテーション、テレカンファレンスなど） Oncology関連の専門知識 Required Skills: Book Writing, Book Writing, Clinical Data Management, Clinical Investigations, Clinical Sciences, Clinical Study Design, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trial Support, Collections Processing, Documentations, Drug Administration, Drug Development, Drug Screening, Ethical Standards, ICH GCP Guidelines, Knowledge Base Management, Legal Document Preparation, Medication Therapy Management, New Technology Integration, Patient Recruitment, Patient Safety, Pharmaceutical Testing, Protocol Development, Regulatory Compliance {+ 1 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: 12/31/2026 *A job posting is effective until 11:59:59PM 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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Responsible for identifying and contracting investigators and medical institutions, as well as managing patient enrollment and safety reporting. The role involves monitoring site progress, verifying case report forms, and collecting information on development and competitor products.