Clinical Quality and Training Lead

Are you highly motivated by being able to make a difference in improving patients’ lives? Are you a high performing executive who is energized by challenges and able to influence people around you? If so, you should continue reading and apply today!

At Novo Nordisk Korea, the position of Clinical Quality and Training Lead provides you the opportunity to work in a high performing team to contribute directly towards the business results while creating values for the Diabetes 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
This position has been opened as part of the team expansion so it is a newly created position. 

As a Clinical Quality and Training Lead (CQTL), you will work in line with corporate/regional/CDC priorities and COEM, plan and conduct clinical quality assurance and clinical training activities to ensure that Novo Nordisk CDC staff are up to date with training and Novo Nordisk Clinical QMS (Quality management System) is functioning in compliance with ICH/GCP and local regulatory requirements in Clinical Development Center (CDC).

Nature and scope of Main accountabilities

Clinical Quality:

• Plan and conduct clinical quality activities in alignment with Clinical Operations Excellence Manager (COEM) to support Inspection Readiness at all times collaborating with Clinical Quality and Training Associate (CQTA)
  • Perform systematic quality checks for key activities such as protocol deviations, informed consent, TMF, etc.
  • Support with Inspection readiness package prepared for the high risk sites in the CDC
  • Identify re-current issues and ensure preventive actions are implemented under COEM leadership
• Coordinate Clinical QMR (Quality Management Review) activities in the CDC including:
  • Tracking of QMR actions and focus area in CDC
  • Monitoring compliance parameters for the CDC
  • Collecting and trending of compliance issues proactively
• Perform GCP Compliance Support Visit (GCPV) to clinical trial sites in alignment with the regional/CDC priorities
• Support with inspection and audit CAPAs (corrective actions/preventive actions) implementation on time
• Support with all local inspections within the CDC
• Act as the local serious breach contact for the CDC
• Act as the clinical deviation expert in the CDC
• Ensure new and updated local regulations are informed in the CDC.

Clinical Training:

• Ensure new hires are trained as required and on time.
• Ensure training gaps are identified by the help of various quality activities and relevant trainings developed or coordinated with the topics experts.
• Plan and conduct GCP and related trainings for external stakeholders
• Coordinate and/or conduct system and process trainings within the CDC, as needed.
• Identify training needs within the CDC and develop trainings in line with regional/CDC needs
• Act as the GCP, NN Clinical Trial SOP and local regulation expert within the CDC

Subject Matter Experts (SME)

CQTL may have additional SME roles. CQTL having SME roles are taking part in global and regional development and improvement projects, identify re-current compliance issues  and provide regional solutions and/or trainings on that specific subjects together with the COEM such as:

Trial product handling

GTCG – Global Trial Coordination Group

Clinical Deviations

CIFG -Clinical Issues Focus Group

TMF –Trial Master File

CT SOP Council

Purpose and subject of interaction with internal/external customers and key contacts

Internal: Approximately 70% of interactions are with internal customers.

Includes: Daily interaction with CDC clinical operations team, region and HQ people.

External: Approximately 30% of interactions are with external customers.

Includes: Investigators, clinical trial site staff other than investigators, authority inspectors and vendors such as local depot responsible, CRO contacts, archiving facility etc

Challenges with regard to innovation and change

• The position requires the understanding of ICH/GCP, local requirements and Novo Nordisk SOPs.
• The position holder needs to adapt to changes in the regulatory environment and internal Novo Nordisk procedures as well as help the team to adapt.
• The position requires innovative use of new IT systems (e-learnings, EDC, IWRS/RTSM, novoGlow, e-TMF, CONNECT, NovoTime, COSMOS and so on).

Qualifications

• Bachelor’s degree or higher is essential, preferably in the discipline of Life Sciences, Medicine or Pharmacy.
• Minimum of 5 years of experience within clinical operations and/or clinical quality and training area, gained in the Pharmaceutical / Healthcare industry.
• The most preferred experience range would be 7-9 years of experience in the relevant field.
• Previous experience of GCP audits and authority inspections is preferred.

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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