Clinical Trial System Manager in Clinical Operations

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Søborg

  • Clinical Development and Medical
  • Søborg

Clinical Trial System Manager in Clinical Operations

Developing interface between business and IT systems

Temporary postion for 18 months

Are you ready to take part in what will be a corner stone in the digitalisation of Novo Nordisk clinical processes, then we have the temporary position for you! We can offer you the possibility to cooperate with highly experienced product managers, product owners, as well as process experts and to interact with stakeholders across the global organisation. This is an important task - and we do it fully Agile and with many global end users and stakeholders in an international environment.

We are looking for a digitally savvy person who understands clinical IT systems that handle clinical trial system data, documentation and communication both from the clinical operations perspective and the systems perspective.

About the department

For 18 months starting Feb-2021, you will be part of the CTMS and eTMF Transformation Teams which are part of the Clinical Operations Office. We support the Global Clinical Operations organisation in conducting clinical trials through expert advice, communication and training, and supporting (IT) tools as part of the digital transformation.

The job

This role is at senior professional level. You will play a key role as full time member of the Transformation Teams developing and implementing innovative and seamless end-to-end processes across trial and document management. You will be working in accordance with the Scaled Agile Framework (SAFe) to effectively secure the business needs and GCP compliant trial management.

Your main responsibility will be ensuring aligment and adjustments between detailed configurations in the Veeva Clinical Suite - Clinical Trial Management System (CTMS), Study Start Up (SSU) and electronic Trial Master File (eTMF). You will ensure that workflows and processes across the Veeva Clinical Suite deliver value and efficiency in the day-to-day work for Clinical Operations globally - CTAs, CRAs, CDCTMs and GDTMs. In addition to the Veeva Clinical Suite, you will also be involved in ensuring seamless end-to-end processes across the investigator portal CONNECT, Veeva Regulatory Information Management (RIM), and Electronic Data Capture (EDC). Furthermore, you will support validation and end user value, you will also have a responsibility to test the workflows as the systems are developed and updated. Finally, you will take part in developing communication and training materials as well as being part of the global roll out of the new CTMS and the updated eTMF.

Qualifications

We are looking for a person with insights into clinical systems and knowledge about clinical trial conduct including document management during a trial (could be a senior Trial Manager or a senior Data Manager). The person must have a positive and solution-oriented mind-set, an in-depth understanding of trial tracking processes and a profound interest in clinical IT system development.

Contact

For further information, please contact Hanne Hvidberg at +45 3079 4118

Deadline

9th of December 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 "Jurist", og befinder sig i kategorien "Økonomi og jura".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 26.11.2020, men kan have været deaktiveret og genaktiveret igen.

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