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Job type : Clinical R & D

Language preference :English

Displaying 601-20listings

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

大手企業のPVのポジションの募集が多い中、小規模な企業にて幅広いPV業務に挑戦することが可能です。


職務内容

* Adverse Event (AE)/ Severe Adverse Event (SAE) のマネジメント
* SUSAEのマネジメント
* クライアントからのICSEの収集および確認
* MedDRAのコーディングのサポート


理想の人材

* PV業務のご経験がある方


条件・待遇

* フレックスタイム制度
* 福利厚生(健康保険等)


To apply online please click th ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

* Safety monitoring in clinical phase 1-4 trials

* Safety information management of investigational oncology drugs

* Evaluation of safety information (global and local studies)

* Entry of safety information and preparation of a draft case report

* Creation of PV-related documentation


Description

* To develop and maintain the Risk Management Plan of the products in Japan based on the PV activities' results and other information

* When the safety issue arises, lead to define the appropriate safety measurement through the communi ...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

* Act as medical expert in interactions with investigators, KOLs, pharmaceutical company / CRO representatives


Description

Clinical Development:
* Oversight, development and execution of clinical studies in line with global strategy. Integrate clinical development objectives with global considerations into strategic business decisions. Ensure clinical, operational and medical governance excellence across all clinical development projects for assigned programs. Lead the preparation of regulatory briefing documents and clinical elements of regulat ...

Job Description

* Clinical site management チームを管理し、臨床研究の実行を率いる
* チームのメインコンタクトを務め、医療機関、プロジェクトチームなどとの連絡を担当する


Description

* Clinical site management チームを管理し、臨床研究の実行を率いる
* チームのメインコンタクトを務め、医療機関、プロジェクトチームなどとの連絡を取る
* Clinical Monitoring Planに従い、プロジェクトの審査、現場訪問、報告書のレビューなどを ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

製薬企業の内勤CRAのポジションで、CRAのご経験を活かしつつ外勤なしでお仕事ができます。


職務内容

* 治験の費用管理・精算業務
* 治験の各種品質管理
* 外勤CRAのサポート


理想の人材

* CRAのご経験がある方


条件・待遇

* フレックスタイム制
* 通勤交通費(全額支給)
* 確定拠出年金制度
* 各種社会保険
* 住宅手当(社内異動時のみ)


To apply online please click the 'Apply' button below. For a confid ...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

Responsible for the supervision of assigned direct reports within Clinical Operations, FSP and/ or Sub-CRO Services Staff


Description

Responsible for detailed performance review and management of assigned direct reports including

Identify individual training needs and assist with the coordination and conduct of training and development efforts, globally

Effectively communicate and develop management strategies, policies and procedures in conjunction with leadership teams


Profile

Clinical Operations

University degree


Job Offe ...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

Ensure from onsite/offsite location a smooth execution of all Pharmacovigilance (PV) activities performed including delivery timeline management and quality control.


Description

Be the preferred point of contact of the client for all Pharmacovigilance issues

Across functions, identify trends and opportunities for improvements. Facilitate sharing of learning across geographies
Provide guidance and supervision on process and delivery to the PV teams (offshore, global team)


Profile

Knowledge of pharmacovigilance (individual case triage o ...

Job Description

<Job details>
■ Ensure site compliance by following Standard Operating Procedures (SOPs) for laboratory qualification, study initiation, routine monitoring, and end-of-study facility visits.

■ To be the primary support person for investigators and site staff. Maintain close cooperation, interaction and effective working relationships with cross-functional teams within the company ...

Recruiter 国際臨床診断薬メーカー
  • ★ ★ Staff Level
Job Description

An R&D Engineer role is now available at a multinational clinical diagnostics company. The applicant selected will ensure the successful development and optimisation of IVD products to secure brand positioning.

Responsibilities:

* Facilitate research and development activities for new products
* Conduct raw material tests and research
* Design R&D and test plans
* Create test reports and data records
* Lead performance analysis, feasibility studies, and product evaluations
* Perform maintenance of laboratory equipment

Requirements:
...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

* グローバルな医療機器臨床試験のすべての段階(フェーズI〜IV)を独力で管理する
* 臨床治験におけるプロジェクトチームを率い、CRO及び他のベンダーを管理する


Description

* 臨床試験計画(CIP)、該当する標準操作手順(SOP)、各国の規制、ISO標準などに従い、グローバルな医療機器臨床試験のすべての段階(フェーズI〜IV)を独力で管理する
* 地域のCTM、CRO及び他のベンダーを管理する


Profile

* 日 ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

長期的にプロジェクトマネージャーへキャリアアップ可能なポジションになります。現在、Sr.CRAの方でマネジメント職に調整したい方、大歓迎です。


職務内容

* 治験実施計画書の作成
* 治験薬概要書の作成
* Feasibilityおよび立ち上げのサポート
* モニターの指名および担当医療機関の割り当て


理想の人材

* 理系の学位をお持ちの方
* ビジネスレベルの英語力
* CRAのお仕事経験がある方


条件・ ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

* Support study teams for Analysis & Reporting of Clinical trial data in liaison with offshore teams
*

Manage communication and management of assigned TA/Portfolio/Segment and provide expert advice and feedback mechanism to offshore delivery teams


Description

* Work with offshore teams to gather requirements from clients

* Contribute to study design and statistical section of the clinical trial protocols

* Develop Statistical Analysis Plan (SAP) or equivalent including table shells

* Perform statistical programming for generatin ...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

* Protocol development and clinical strategy within assigned TA, with close collaboration with the Head of Clinical Research Japan

* Integral in the scientific planning, execution and reporting of Japanese clinical studies for compounds within the inflammation, infectious disease and oncology therapeutic areas.


Description

* Act as local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.

* Provide scientific support to function ...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

*

Responsible for independent oversight of global clinical trials in all phases, from start to finish
* Provide leadership in cross-functional project teams conducting clinical research trials, while being responsible for CRO and other vendor management


Description

*

Drive operational excellence of clinical trial plan in accordance to standard operating procedures (SOPs), Japan regulations, ISO standards
*

Independently manage the clinical trials (Phase I-IV) of the investigational medical devices , in accordance with applicable s ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

臨床開発業界にてお仕事経験がある方はCTMサポート役(CTA)として臨床試験に関する知識を活かしてお仕事をすることができます。


職務内容

* 治験文書の確認・管理
* FAQ、データ管理、逸脱の書類の確認などのサポート業務
* 治験に関する費用のマネジメントのサポート


理想の人材

* 理系の学位をお持ちの方
* CTAまたはCRAとしてのご経験がある方


条件・待遇

* フレックスタイム制
* 出産・ ...

Recruiter (Company is not publicly visible)
  • HIGH CLASS
  • ★ ★ ★ ★ Manager Level
Job Description

Responsible for the supervision of assigned direct reports within Clinical Operations, FSP and/ or Sub-CRO Services Staff


Description

Responsible for detailed performance review and management of assigned direct reports including

Identify individual training needs and assist with the coordination and conduct of training and development efforts, globally

Effectively communicate and develop management strategies, policies and procedures in conjunction with leadership teams


Profile

Clinical Operations

University degree


Job Offe ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.

Actively contributing to process improvement and site management, you will train and mentor Site Managers (SMs) and other Local Trial Managers (LTMs).


Description

- You will undertake assessments (country do-ability, and site feasibility) to select suitable trial sites and assign SMs
- Development of the SOP document
- Leading and coordinating local tri ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

* Responsible for the initiation, planning, execution, monitoring and closure of projects at the project level.


Description

* Provide input and support development of the project strategy.

* Responsible for leading cross-functional project teams to ensure that project deliverables are achieved and issues and risks are identified and managed.

* Effectively manages project stakeholders while working within a matrixed environment.

* Prepares routine project status updates via formal and informal channels (monthly reports, project revie ...

Recruiter (Company is not publicly visible)
  • ★ ★ Staff Level
Job Description

現在、Sr.CRAとしてご活躍されている方でCTMとしてキャリアップしたい方、大歓迎です。


職務内容

* ICH-GCP, J-GCPを遵守した臨床試験の運営・品質管理・財務管理
* 担当プロジェクトにおけるグローバルチームとの連携と顧客対応業務
* 担当プロジェクトチームのマネジメント


理想の人材

* CRAのご経験がある方


条件・待遇

* フレックスタイム制
* 通勤交通費(全額支給)
* 財形制度
* 各種社会 ...

Recruiter (Company is not publicly visible)
  • ★ Entry Level
Job Description

* (未経験OK!)薬事申請関連書類の通訳、編集、提出、及びプロセスの管理
* 政府機関、海外支社とのコミュニケーション


Description

* 薬事申請関連書類の編集、審査、提出、プロセスの管理、戦略の立ち上げ
* 政府機関、海外支社とのコミュニケーション
* PMDA/MHLWによる薬事申請関連規則の情報収集、解釈、会社基準のコンプライアンス確認


Profile

* class I/ II/III / IV の医療機器の薬事申請(RA)経験 ...

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