Risk Based Monitoring Specialist
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Søborg
- Clinical Development and Medical
- Søborg
Are you able to drive and sustain implementation of Risk Based Monitoring (RBM) in Novo Nordisk?
Our Centralised Monitoring Unit (CMU) drives the implementation and anchoring of RBM and ensure compliance with the new regulatory requirements.
In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics.
About the department
The CMU is a department in the Trial Operations Center of Expertise anchored in the Trial Management and Reporting Area in Global Development. The TMR Area consists of approximately 300 highly skilled people based in Denmark and India, responsible for providing data and trial management expertise, data management resources to clinical development projects, tools for centralised monitoring and support to our global clinical IT systems as well as clinical reporting.
We work closely with all other skill areas in Global Development, i.e. Trial Management, Clinical Pharmacology, Biostatistics, Medical & Science as well as with our Global Development Global Service Center (GD GSC) 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 clinical data surveillance, medical data review, development of reports for centralised monitoring and process facilitation to enable regulatory compliance and drive 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 of RBM.
Together with a specialist colleague, you will be responsible for the driving RBM implementation via facilitation of risk assessment workshops, 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. Training and change management are essential components of the job.
The RBM specialists are collaborating closely with other functional areas in Global Development as well as with our colleagues in the Clinical Medical and Regulatory organisation and will be responsible for development and operational execution of RBM.
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. Experience with RBM will be an advantage.
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 and data presentation. 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 patient-care. 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 Bo Maach-Møller +45 3079 5437.
Deadline
8th December 2019.
Applications will be reviewed on a rolling basis
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 chronical 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 19.11.2019, 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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