EventAdjudication Specialist/Coordinator
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Bagsværd
- Clinical Development and Medical
- Bagsværd
Safety Operations – Maternity cover for Event Adjudication Coordinator
Are you interested in Event Adjudication and Clinical trials? Do you want to cooperate with stakeholders across the organisation? Are you able to use subject matter expertise and keep people engaged and driven to meet project goals?
Can you handle high pressure situations and deliver to the expected quality? Are you a role model for the Novo Nordisk code of conduct? Then we may have just the right job for you. We are looking for a temporary (12 months) Event Adjudication Coordinator to join our Safety Operations Event Adjudication department from August 1st, 2020.
About the department
The Event Adjudication department belongs to Safety Operations, one of the functional areas in Global Safety, and is situated in Bagsværd, Denmark. Global Safety is an organisation of more than 400 highly skilled professionals responsible for the global handling and reporting of adverse events, and the quality of Novo Nordisk clinical development and marketed products.
The Event Adjudication department consists of 22 highly engaged team members from various academic backgrounds; who work in a fast-paced environment reflecting the increasing demands from numerous long-term clinical trials and regulatory authority requirements. An increasing number of trials require certain clinical adverse events to be adjudicated. Event adjudication is a process where an independent review board of medical specialists assesses the relevant events for fulfilment of pre-defined clinical criteria.
The department works in an informal, fast-paced atmosphere with multiple global stakeholders across Novo Nordisk and internationally based external service providers.
The position
As an Event Adjudication Coordinator you will be the driver of cross-functional coordination of event adjudication activities with relevant areas in Novo Nordisk to ensure a smooth and effective process set up for current and new projects. You are the first point of contact for the organisation and external supplier when initiating Event adjudication activities and will use your organisational understanding and clinical knowledge to support this process. You will be involved in optimisation and standardisation across clinical projects to efficiently support event adjudication activities across projects and ensure best practice regarding event adjudication in Novo Nordisk.
You will represent Novo Nordisk in meetings with external adjudication suppliers, with focus on start- up activities and overall cross trial collaboration. You will represent Global Safety in relevant cross-functional teams within Novo Nordisk and in international groups regarding event adjudication. Furthermore, you will be responsible for ongoing surveillance of external EA regulatory guidelines and communication of any changes/updates to relevant stakeholders. You will contribute to continuously improving the efficiency and compliance level of our processes ensuring that we are set for the future both in terms of growth and authority requirements. Finally, you will drive training activities and play a key role in audits and inspections.
You will work closely with management within the department and on clinical trial projects. Your success in this role is dependent on your cooperation and communication skills, your analytical skills and ability to identify and address challenges in a timely and proactive manner. The job will require some travel.
Qualifications
You have a Master’s degree, preferably within Biomedical Sciences (e.g. Medicine, Pharmacy, or Veterinary). You have a solid experience in event adjudication, Good Clinical Practice and practical experience in project management as well as experience with working with CROs.
You are highly skilled with MS Office and specifically high level of excel knowledge is required. Furthermore, you find it easy to master new IT systems and you are used to work with databases and reporting.
You have a quality mind-set, can do attitude and are able to drive innovation and alignment across the department and the organisation. You are a strong communicator and can act as an empowered representative of the event adjudication department.
You are comfortable interacting with stakeholders at any organisational level and you have experience in working across organisational and geographical boundaries. Leading others in project contexts comes natural to you, and you use your energy and understanding of other people to ensure timely involvement of the right competencies in the right processes and carry projects ideas through with success. Finally, you are fluent in English, both written and spoken.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information about the job please contact Kirsten Bang Rungby (+45 3079 6242) or Ane Skou Elgaard (+45 3075 0958).
Deadline
17 April 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 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 3.4.2020, 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.
- Øvrige
- Bagsværd
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