Clinical Development Center (CDC) Project Manager

Would you like to join a team that plays a crucial role in the ambitious drug development programmes at Novo Nordisk? Are you a dedicated clinical professional who enjoys working in dynamic and multicultural work environment? Then you could be our new Clinical Development Center Project Manager. Apply now and join us for a life-changing career!
 

About the department
The Medical Affairs Department promotes the best-in-class medical affairs activities on a global level for the Novo Nordisk Diabetes, Rare disease, and NSCD (New Serious Chronic Disease) portfolio, collaborating cross-functionally with both local and global teams. 
The person in this position will report to the Clinical Operations Manager.

The position 
The role is accountable for multiple clinical trials management in the Korea Clinical Development Center (CDC), and ensuring deliverables are met as per project timelines, within the budget and complying with Protocol, regulatory requirements, International Conference on Harmonization – Good Clinical Practice (ICH-GCP) and Novo Nordisk (NN) Standard Operating Procedures (SOPs).

Your main tasks will include but not limited to:

• Trial management activities from site selection to post-clinical trial activities, inclusive of milestones, managing overall trial organisation and coordination within the country including assessing feasibility, planning resources and budget, risk analysis and developing a strategy for trial implementation.
• Ensure approval of local IMP label and coordinate handling of trial products as applicable. Prepare the country recruitment and mitigation plan including consolidating the CRA site plans and monitor recruitment and retention of trial subjects and take appropriate actions according to the agreed country plan.
• Coordinate tasks and communicate between Regional or Headquarter Trial Managers. Monitors Clinical Research Associate (CRAs) in order to facilitate progress and global coordination of the clinical trial programme. Manage escalating issues to the local line manager, Regional Trial Manager or Headquarters Trial Manager (RTM or HQ TM) and seeing to consistency between the trial sites and CRAs.
• Proactively drives clinical trial activities forward and delivers results that have a direct impact on the successful completion of the clinical programme. Consolidate systems and vendor input per country as applicable (e.g. Case Report Form (CRF) and diary).
• Responsible for the country budget of assigned clinical trial(s). Proactively identify potential risks at a country level and take actions by communicating to the CRAs and/or RTM/HQ TM and/or Clinical Operations Manager/Clinical Research managers.

Qualifications

• Bachelor’s degree in Pharmacy, Life Science or Nursing is required.
• Previous experience in monitoring clinical trials in accordance with ICH GCP and at least 5-7 years Trial management experience is mandatorily required.
• Proficiency in communication both in English and Korean.
• Demonstrate strong Project Management expertise to handle a large number of minor and major tasks with flexibility, coming from different stakeholders. 
• Computer literacy and IT skills utilizing SAP, Clinical Trial Management System (CTMS), Electronic Data Capture and electronic Trial Master File (EDC & eTMF).

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact
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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