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Risk Based Monitoring Specialist in Global Development

Contrato de Directores de administración y servicios en HOVEDSTADEN (Dinamarca)

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Ledelsesarbejde : Ledelse inden for administration og erhvervsorienterede funktioner : Ledelse inden for forretningsservice og administrative funktioner : Ledelse inden for anden forretningsservice og andre administrative funktioner

Descripción de la oferta de trabajo:

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 departmentThe CMU is anchored in Clinical Systems, Data & Trial Management (CSD&TM) which today consists of approximately 200 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.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 enable 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 RBM across the global NN organisation.The positionWe are looking for a Risk Based Monitoring 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 CMR organisation and will be responsible for development and operational execution of RBM.QualificationsYou 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.Working at Novo NordiskNovo Nordisk is a world leader in diabetes 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.ContactFor further information, please contact Inge Hansen at +45 3077 5502.Deadline12 June 2018.

Servicio de empleo de origen: AMS, Servicios Públicos de Empleo, Dinamarca.

País del trabajo: Dinamarca.

Región: Hovedstaden.

Ver 681 ofertas de trabajo en "HOVEDSTADEN" (Dinamarca).

Fecha de inicio: 01/06/2018.

Nº de vacantes: 1.

Nivel educativo requerido: Sin especificar.

Cómo solicitar el puesto: Inge Hansen

Empresa: Novo Nordisk A/S.

Contacto: Johannes Mols

Teléfono: 30775502.

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