Clinical Research Manager

Are you passionate about the world of clinical trials? Are you highly motivated by being able to make a difference in improving patients' lives? The position of Clinical Research Manager provides you the opportunity to work in a high performing team to contribute directly towardsclinical operations while creating values for people living with diabetes and other serious chronic diseases. Join us and apply now!
About the Department
Clinical Development and Medical Department provides timely, accurate and updated scientific expertise to drive business services to Novo Nordisk in all therapeutic areas. Our working environment is characterized by interesting and demanding assignments and continuous professional development opportunities. The position Clinical Research Manager is to be located at Tokyo, Japan and report to the Clinical Operations Senior Director.
The Position
Clinical Research Manager (CRM) works as the line manager for Clinical Research staff: Clinical Research Associate (CRA) and/or Trial Manager (TM) to ensure the implementation of clinical trials that includes the job of site selection, application to Institutional Review Board (IRB), delivery of clinical supplies, monitoring, Source Document Verification(SDV), collecting Case Report Form (CRF)s/ Data Collection Form (DCF)s, drug accountability and site closure in compliance with GCP/SOP and other regulations. CRM also works a Senior Trial manager TM role, aims to have an efficient and seamless clinical development without compromising the quality as a clinical leader of the project development team. CRM selects suitable investigators/institutions for a project and conducts the trials according to the plan. In addition, CRM assists TM/CRAs in supervising high-quality monitoring activity (recruiting, monitoring, CRF&DCF etc.) according to Good Clinical Practice (GCP) and SOPs, as well as being in-charge of preparing Trial Master File (TMF), manages/updates it to assure the quality of clinical d ata and submits notification to the government and Pharmaceuticals and medical device agency (PMDA) in the suitable time.
Key tasks include, but are not limited to:

• Manage the team member. Ensure the On the Job Training (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.
• Organize and lead a study team appropriately and work with 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) and translate protocol into Japanese. Make operation plans (including a patient enrolment plan, CRF collection plan and a monitoring guideline) with other CRMs.
• 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 and 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. Together with ITM, data management and statistics analysis to create the Clinical Trial Report (CTR). Prepare TMF and update it to secure the quality of the document.
• Manage with the internal Audit, GCP inspection and paper review sufficiently with other CRMs. Estimate and draw up the clinical budget (as accurately as possible) with other CRMs based upon the planned trials. Submit notification to the government or PMDA in the suitable time.

Qualifications

• Minimum of 10 years of experience in clinical operations, working on GCP clinical trials as CRA or TM. Similar experience as CRA or TM in a similar job within pharmaceutical industry will also be taken into consideration.
• Experience in entire Clinical Trial Process (from Site selection until Trial Closure)
• Communicational level English (speaking and writing) and native level Japanese are required.
• Communication/Presentation skill for smooth communication with global team, Study team, CRAs and TMs
• Already showing Leadership to CRAs/Trial managers/study team, people management experience is preferred.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales - we're all working to move the needle on patient care.
Contact
Kindly upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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