クリニカルリサーチマネージャー

日付: 2022/06/25

場所: Chiyoda, Tokyo, JP

会社: Novo Nordisk

       

Are you highly motivated by being able to make a difference to improving patients’ lives?    Are you a high performing professional who is energized by challenges and able to motivate people around you? If so, you should continue reading …
In Novo Nordisk Japan, the position of Clinical Research Manager provides you the opportunity to work in a high performing team to manage the correct execution of global trials while creating value for patients.

 

 

About the Department

 

The Clinical, Medical, Regulatory (CMR) department is one of the key functions that enable the business strategy through effective execution of functional goals, in the areas of Clinical Research, Medical Affairs, and Regulatory. 
The position Clinical Research Manager is to be located at Tokyo, JAPAN, and report to the Senior Director of Clinical Operations.

 

 

About the role

 

The Clinical Research Manager (CRM) has a role of line manager for Clinical Research staff (CRA and/or TM) to ensure the correct implementation of clinical trials including site selection, application to IRB, delivery of clinical supplies, monitoring, SDV, collecting CRFs/DCFs, drug accountability and site closure in compliance with GCP/SOP and other regulations.
Additionally the CRM also acts as a Senior Trial manager (TM) .
As a clinical leader of the project development team, the CRM ensures that clinical development proceeds smoothly and speedily without compromising the quality. CRM selects suitable investigators/institutions for a project and conducts the trials according to the plan. CRM assists TM/CRAs in supervising high-quality monitoring activity (recruiting, monitoring, CRF/DCF and IMP collection, etc.) according to GCP and SOPs. CRM is also responsible for preparing Trial master file, manages/updates it to assure the quality of clinical data and submits notification to the MHLW/PMDA in the suitable time. 

 

 

Responsibilities 

 

1 Team management.
      - Ensure the OJT training of team members (CRA or TM) to improve and keep quality (the job of site selection, application to IRB, delivery of clinical supplies, monitoring, SDV, collecting CRFs,

        clean- up CRFs, drug accountability and termination application in compliance with GCP/SOP and other regulations.)
      - Collaborate with relevant colleague to handle line-related issues for purposeful people-development and better working climate.      
2
 Organize and operate a study team appropriately and support project team to create the plans of the new project development such as strategy planning, CDP preparation, etc.
      - Design protocol based on the Trial outline (TO).
      - Translate protocol into Japanese.
      - Make operation plans (including a patient enrolment plan, CRF collection plan and a monitoring guideline) with other CRMs.    
3
 Manage the study team members and relevant staff in order to prepare a clinical trial, conduct a clinical trial, collect data and perform QC check on schedule.
      - Approve labels for IMP.
      - Assist CRAs for monitoring activity (recruiting, monitoring, CRF&DCF collection, etc.) according to GCP and SOPs.
      - Find the cause of delay and its solution, if a schedule is behind and give advice and instruction to concerned staff
4
 Support ITM, data management and statistics analysis to create the CTR
5
 Prepare TMF and update it to secure the quality of the document
6
 Cope with the internal Audit, GCP inspection and paper review sufficiently with other CRMs
7
 Estimate and draw up the clinical budget (as accurately as possible) in cooperation with PD and other CRMs based upon the planned trials
8
 Submit notification to the MHLW/PMDA in the suitable time

 

 

The Qualifications

 

- Experience in clinical Operation (working on GCP Clinical Trials as CRA or TM) for at least 10 years (experience as CRA, TM or similar job in other Pharma should be taken into consideration)
- Experience in entire Clinical Trial process (from Site selection until Trial Closure, at least 3 trials)
- Experience in leading Global studies, balancing speed, cost and quality, with senior Trial Manager level skills
- Experience in leading GCP inspections by HA, including FDA inspection
- High level communication skills with internal and external stakeholders, including HCP and Global members
- Ability to set and execute clear and challenging goals from a business perspective
- Intermediate ~ well English level to communicate with Global members (TOEIC S/W score >=270) 
- Already showing Leadership to CRAs/TM/study team
- Have a high level of quality awareness and a NNWay mindset
- Understand and encourage D&I concept/approach
- Propose and encourage innovations
- Master's degree and/or any qualification (e.g. pharmacist) is preferred

 

 

Working in Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Novo Nordisk is a global healthcare company with almost 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 48,100 people in 80 countries and markets its products in more than 170 countries.


Contact

Please send your CV online (click on Apply and follow the instructions).

Deadline

We will review your applications as you apply!

私たちはインクルーシブな採用プロセスと、全ての求人応募者様へ公平な機会を提供することにコミットしています。

 

ノボノルディスクでは、これまで考えてきた「世界で最高の企業」になろうとするだけでは不十分であり、「世界にとって最高の企業」になろうとすることが必要だと考えています。そしてそれは様々な視点、経歴、文化を持った有能な社員がいてこそ、成し遂げることができます。私たちはそのために、社員、患者様やコミュニティにおける多様性(ダイバーシティ)を祝福するインクルーシブな企業文化を作ることにコミットしています。
一緒に人生を変えていきます。