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UDLØBET

Novo Nordisk

RBQM Specialist

Fuldtid

Permanent

Vandtårnsvej 108, 2860 Søborg, Danmark

SE PÅ KORT
ID: 2526332
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Indrykket for 51 dage siden

Do you want to make a difference in how we setup and oversee clinical trials in Novo Nordisk? Do you agree that by investing time in setting up trials the smartest way, we can safeguard participant safety and ensure data integrity better in a more structured and efficient way? 
 
If yes, you are the RQBM Specialist or Advisor we are looking for. 

Apply now for a life-changing career!
 
The position
We are looking for an RBQM Specialist or Advisor (depending on seniority) to be part of driving and anchoring the implementation and continuous improvement of RBQM.
 
Your key responsibilities will include:

  • Drive the discussions and challenge the trial squad members designing the trial and data capture. Together, you will decide which data and processes are critical and whether any of the associated risks can be mitigated by design. 
  • Have a key role in developing the monitoring strategy for the trial by bringing together all the relevant skill areas doing monitoring (CRAs, trial managers, data managers, medical staff).
  • Support the trials ongoing risk assessment during conduct and ensure learnings are captured for future trials.
  • Refine how we handle risks in trials to ensure uniformity where appropriate.
  • Develop the role in Novo Nordisk to become a key stakeholder for the trial squads in ensuring continuous oversight of the trial. This may include creating tools, and guidance as required to support the SOPs and processes.
  •  
    Your daily work will include collaboration with trial squads to implement a risk-based mindset to embrace the RBQM framework in trial setup and conduct. You will be involved in trials investigating different drugs in different indications, so no days will be similar, and you will get to know many parts of the clinical organization.
     
    Qualifications
    To succeed in this role, we expect you to have: 

  • MSc in natural sciences or similar.
  • Experience in the pharmaceutical industry, that would be a preference.
  • A thorough end-to-end understanding of clinical development for a specialist role.
  • Active experience with RBQM is an advantage.
  • Professional proficiency in English.
  •  
    As a person, you are open-minded and a team worker, appreciating cross-cultural work and a great collaborator with stakeholders. You have demonstrated analytical skills and excel at tutoring and you are comfortable yet respectful in challenging trial squad members in critical thinking and quality mindset.
     
    About the department
    The CMU (Central Monitoring Unit) is a Danish HQ department in Clinical Drug Development. We define the RBQM framework of Novo Nordisk, support trials in using the RBQM framework, drive behavioral change toward a risk mindset, and execute central monitoring together with our sister department in Bangalore.

    We are a diverse team working in a hybrid setting with colleagues in four global locations and with diverse backgrounds (CRA/ monitor, trial manager, medical and safety) and a lot of drug development experience, but less RBQM practice, so we are welcoming all opinions and appreciate experience.
     

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