Johnson & Johnson Careers

【Medical】 CMO Office, Clinical Trial Manager (Senior Specialist)

Chiyoda, Japan
Clinical Research non-MD


Job Description

Requisition ID: 1805690766W

【Medical】 CMO Office, Clinical Trial Manager (Senior Specialist)

 
[JD]

This position is responsible for the successful execution of local, regional, and/or global trials (clinical trials, company-initiated studies (CIS), Post Marketing Surveillance (PMS) and so on) for assigned projects/studies; this includes undertaking adequate planning, obtaining deliverables within agreed timelines and budgets, ensuring high quality, and meeting all of the company's Standard Operating Procedures (SOP) and regulatory requirements. This position leads the clinical team members (Product manager, Regulatory Affairs lead, Clinical Operation team including CRO). The position is also responsible for the alignment of goals with organizational objectives.

 
[Detail]

1) Ensure trials (clinical trials, CIS, PMS and so on) to be conducted in compliance with GCP/ GPSP/ SOPs, local regulatory regulations, procedures, and protocols as Clinical Trial Manager (CTM)

2) Ensure any adverse events known from trials to be reported properly

3) Develop and ensures accurate budget management for assigned trials. This includes ensuring that vendors and affiliate budgets are tracking according to plan. Updates are made to account for changes in the scope of the trial. Ensure project execution according to timeline and budget

4) Plan for study budgets and collaborate with Clinical Lead to manage the development of Investigator agreements and site contacts within fair market value, payments and financial disclosures as needed.

5) Drive the preparation of recruitment/contingency plans and implement ad campaigns as required. Ensures that enrollment commitments meet projected enrollments at the clinical trial level, monitors patient recruitment, and ensures timely and accurate documentation, communicating study progress and issue escalation.

6) Create and update study-specific documents such as Project Operation Manual, Monitoring Plans, Informed Consent Form, device related documentation, and site feasibility related documents by collaboration with Clinical Lead.

7) Ensures compliance with global/Local health authority regulations and guidelines and internal operating procedures and processes. Participates in preparing for and conducting. Ensures that the Clinical team operates in a constant state of inspection-readiness. Works with Quality Management liaisons to ensure quality oversight of assigned trials, using all available tools.

8) In coordination with Clinical Lead, Clinical Operation Associates, Study Medical Lead and/or members of the Global team, CTM is responsible for providing appropriate trial-specific training to the internal/outsourced trial team members and the site study staff. He or she works to set up and coordinate Investigator Meetings, where applicable.

9) Ensures that deliverables are provided according to the trial plan. Provides updates to all internal/outsourced trial team member on the status of deliverables. Ensures that all required reports are generated and made available for real time tracking of the trial status, in accordance with the trial plan.

10) Develop and maintain working relationships with others requiring interaction and mutual support

11) Select and oversight External Service Providers(ESPs) included the Contract Research Organization (CRO) by collaboration with Clinical Lead.



Qualifications
 <職務経験>
・医薬・医療機器の臨床開発経験を5年以上有する
 
<必要とする能力・スキル>
・GCP及び薬事・薬機法等関連法規
・コミュニケーションスキル
・英語(reading、writing、speakingなど、TOEIC730以上、若しくは同等)
・パソコン操作、Word、Excel、PowerPoint,EDCやCTMSなどのシステム
 
<資格/免許>
・大学学部卒以上
 
<求める人物像> 
円滑な業務遂行のため、社内外の関係者と良好な関係を構築する意識とコミュニケーション力を持っている人。
業務の成果達成に対して責任をもち、常に前向きに取り組める人。
 


Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Johnson & Johnson K.K. (8235)
Job Function
Clinical Research non-MD
Requisition ID
1805690766W