Risk Based Quality Management Advisor

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Søborg

Do you want to make a difference and optimise how we set up and oversee clinical trials in Novo Nordisk? Would you like to contribute to safeguarding participant safety and ensuring data integrity in a more structured and efficient way? This is exactly what this job in RBQM (Risk Based Quality Management) is all about, we want to take it to the next level. Apply now and join us as Risk Based Quality Management Advisor. The position We are looking for different skill sets:
  • Clinical pharmacology experience to influence how clinical pharmacology trials are executed under RBQM (including using a digital solution)
  • Clinical operational and RACT experience to development fit4future risk assessment process
  • Risk management experience to further enhance structured risk management methodologies into the way we work
    • Key responsibilities include:
  • Facilitate risk assessment discussions with trial team members. Together, you will decide which data and processes are critical for the trial and the handling of risks related to those;
  • Support development of monitoring strategy for trials by bringing all relevant skill areas into play (CRAs, trial managers, data managers, medical staff);
  • Support trial risk assessment during conduct;
  • Support development of RBQM partner role to become a valuable stakeholder for trial teams;
  • Topic lead or contributor in sub team;
    • Qualifications To succeed in this role, we expect you to have:
  • Bachelor’s or Master’s degree in natural sciences or other relevant fields
  • Experience working in the pharmaceutical industry, preferably with clinical trials and/or RBQM
  • Proven track record with project or process management
  • Ability to facilitate workshops with multiple and diverse stakeholders
  • Fluency in English, verbally and written
    • On a personal level, you have a consultative approach and strong facilitation skills to guide discussions, mediate, and support others to make informed decisions. Overall, you are a team player, who enjoys working with others to achieve shared goals, fostering open communication, cooperation and desire to contribute to an active and engaged team. About the department You will join RBQM Office which is a Headquarter-department in Clinical Drug Development, located in Denmark. We define the RBQM framework of Novo Nordisk which includes driving the behavioural change which is needed to succeed with RBQM. The department supports trials in risk assessments and implementation of those decisions, maintains and drives business processes related to RBQM, keeps training relevant for end users, ensures audit and inspection readiness and oversees statistical monitoring and soon central monitoring in close collaboration with our colleagues in Bangalore. Moreover, we deliver business support to implementation of the digital platform which will enable data analytics to be used in the monitoring process, hence impacting big parts of the organisation. We are expanding, so the team is moving into new ways of working, namely self-organising sub-teams. Going forward, our ambition is to work in learning cycles to be able to deliver to our customers and drive development based on learnings. We are a diverse team working in a hybrid setting with colleagues in several global locations, hence acceptance of some variance in working hours is to be expected, due to time zones. Relocation packages may be available for the right candidate, however, virtual work options are also possible in some locations. 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 For further information, please contact Ida Holme, Head of The RBQMOffice, at [email protected] Deadline 31 October 2023. To ensure a fair and efficient recruitment process, please refrain from adding a photo to your CV or resume. 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.


    Information og data

    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 12.10.2023, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Forretningsudvikler
    • Søborg
    Rapportér

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