Risk based monitoring Specialist
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Søborg
- Clinical Development and Medical
- Søborg
Risk based monitoring Specialist
Are you able to drive and sustain implementation of Risk Based Monitoring (RBM) in Novo Nordisk?
Would you like to work in Denmark anchoring RBM globally while ensuring compliance with the regulatory requirements? Then we have an opportunity for you within the CMU (Central Monitoring Unit).
About the department
The CMU is a department in the Trial Operations Centre of Expertise anchored in the Trial Management and Reporting Area in Global Development. We work closely with all other skill areas in Global Development, i.e. Trial Management, Biostatistics, Medical & Science as well as with the CMU Global Development Global Business Services (GD GBS) in India, and the global Clinical, Medical & Regulatory (CMR) organisation.
The CMU enables decision making in clinical trial conduct across the global clinical trial portfolio. Key deliverables from the CMU are defining, executing and supporting RBM in Novo Nordisk and to drive the realisation of its value. We continuously develop the RBM framework, directly support trial teams during setup and execution (incl. central monitoring) to enable regulatory compliance and optimal implementation of risk-based study execution across the global NN organisation.
The Job
We are looking for a Risk Based Monitoring (RBM) Specialists who will be part of driving and anchoring the implementation and continuous improvement of RBM.
You will contribute to this in several ways:
• By supporting the trial teams via facilitation of risk assessment workshops, define monitoring strategies, define reports relevant to monitor identified risks centrally (trial management and medical), aligning risk handling across projects, provide guidance for development of monitoring plans and adjust approaches as learnings are harvested.
• By designing and performing of global training and change management to ensure the success of RBM in both Global Development and CMR based on a close collaboration with CMR and GD stakeholders.
• By continuously improving and developing effective tools and processes of which some will be together with the digital teams.
Qualifications
You have a master’s degree in natural sciences or similar and significant work experience from the pharmaceutical industry. You have a thorough end-to-end understanding of clinical development, leadership and project management experience with a proven track record in delivering results via teamwork in a cross-cultural setting. Active eexperience with RBM is a must. Experience in product life cycle and development of newer technologies for RBM will be an advantage. Experience in process mapping will be desirable.
You must be fluent in English, have a proactive mind-set and ability to work independently in a continuously developing environment. You possess proven strong analytical skills, and you excel in tutoring. You are well organised, a strong communicator, and have solid problem-solving capabilities. You can keep your spirits high even when under pressure, and you can collaborate at any organisational level.
Novo Nordisk is a world leader in diabetes and obesity care. Our success is built on more than 90 years of innovation and commitment to patientcare. We combine world-class scientific, pharmaceutical, and clinical expertise with the highest ethical standards to continue to improve the quality of life of millions of patients across the world.
Contact
For further information, please contact Birgitte Esmarck Meibom +45 3079 8042.
Deadline
25 November 2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 12.11.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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