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Computer Systems Validation Specialist

 
Requistion ID:  1275
Location: 

Copenhagen, N/A, DK

Date: 
 

Computer Systems Validation Specialist – Digital Technologies

 

Description

 

Are you passionate about ensuring the digital solutions used in clinical trials to improve the quality of life for people living with brain diseases are validated and meet the regulatory requirements?

 

Then we may have the right job for you as we are currently looking for a Computer Systems Validation Specialist to ensure our systems and applications utilized in the conduct of our clinical trials are validated and inspection ready.

 

The position is in Digital Technologies, which is part of the Biometrics Division. This team is managing, supporting and implementing digital solutions utilized in all stages of our clinical trials, from applications used in site selection, clinical trial management, investigator portal, data capture, visualization and reporting. The system landscape includes industry standard systems, such as RAVE, SAS, EntimICE and Spotfire and is complemented with systems specifically tailored to Lundbeck’s requirements. We work with a combination of on-premise and in cloud systems. Our team covers several areas of specialty, including digital health technologies, business analytics, and data engineering.

 

The position is placed at Lundbeck’s headquarter in Copenhagen, Denmark.

 

 

Your job and key responsibilities

 

You will primarily be working with systems related to our clinical data, including tools for monitoring patient safety, optimizing clinical trial operations, applications for data capture, an investigator support portal, and mobile apps.

 

You will be working closely with colleagues in Biometrics, Experimental Medicine and Clinical Development, IT and Quality Assurance departments, as well as with external consultants.

 

Part of your key responsibilities will to be ensure that our systems are maintained in a validated state and compliant with internal procedures and external regulations. You will be responsible for several projects requiring validation in a GxP environment, and responsible for in-sourcing/out-sourcing related work.

 

Qualifications

 

Our preferred candidate has the following profile:

  • You have a master’s degree in a Technical or Life Science related field
  • You have at least 5 years’ work experience with validation of GxP computerized systems (e.g. GAMP, 21 CFR Part 11, and other regulations) in an international medical device or pharmaceutical company
  • You have experience with outsourcing and insourcing of validation tasks
  • You have a good understanding of Clinical Research, Data Management, Statistical Analysis & Reporting
  • You are a great communicator and are able to efficiently describe complex system architectures
  • You are analytical, goal-oriented, innovative and proactive
  • You have strong interpersonal and team skills and coordinating skills
  • You are fluent in written and oral English

 

Further information

 

For further information please contact Manager Paula Petcu at +45 3083 2372 or Senior Director Alastair Clewlow at +45 3083 3921. We also recommend you visit our website www.lundbeck.com

 

Your application

 

Please click on the link below to apply for the job. Applications must be received no later than 16th August 2020.

 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.


An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.