Clinical Support Specialist (Clinical Trial Administrator)

Would you like to play a key role in the development of our growing portfolio together with a friendly, ambitious and professional team of Clinical Support Specialists (CSS)?

LEO Pharma is committed to improving the lives of people with skin diseases around the world. With our ambitious aspiration to help more than 100 million people by 2020, LEO Pharma is looking at new and innovative solutions - now also entering into development of biologic treatments. LEO Pharma is set to become the world dermatology leader – offering the most diverse range of treatment solutions to meet the individual needs of people with skin diseases. 

Add value to Clinical Trial Specialty deliverables

As a CSS you are an integral part of the global clinical trial teams in LEO Pharma. You will drive processes supporting everything from clinical trial start-up through to clinical trial reporting. The deliverables begin with the Clinical Trial Protocol and ends with the Clinical Trial Report and final archiving. In between, the CSS support the entire trial team with the specialised deliverables, i.e. Investigator Trial Files, Project Manager support, site supplies, document review and handling and much more.

Your main responsibilities as a CSS will be:

  • to be part of clinical trial teams and responsible for specialty deliverables and support to the team members
  • establishing and maintaining the Trial Master File (TMF) documents together with the clinical project manager, the CRA and the CRO
  • to ensure quality and completeness of the electronic TMF
  • to drive the Investigator Trial File creation process to ensure timely delivery at trial sites
  • to ensure essential documents meet technical requirements for electronic submission
  • to ensure the administrative completeness of the clinical study protocol and report

Qualifications

You have a Bachelor’s degree with experience in an administrative position, preferable  CTA experience from the pharmaceutical industry.

You have solid skills in driving processes, handling and organising tasks. You thrive in an international environment where excellent stakeholder management is a key requirement.

The ideal candidate has most of the following skills:

  • Knowledge of ICH/GCP
  • Fluency in written and verbal English
  • Ability to prioritise and handle many varied tasks each day
  • Ability to work consistently, keep focus on details while maintaining speed and quality
  • Knowledge, flair and interest for working in Document Management systems as well as Trial Management systems, such as IMPACT
  • Knowledge of eTMF systems, such as Veeva Vault

Our ideal candidate has a strong customer service mind-set, good collaboration skills and a good sense of humour.

Global Clinical Operations – your new work place

Global Clinical Operations is responsible for all LEO Pharma sponsored clinical trials from phase I-III. In Clinical Support Services you will have 10 colleagues, placed in two countries, who are dedicated to the CSS role in our clinical trials. This position will be based at our headquarters in Ballerup, Denmark.

Further information and application deadline

In case you have any questions, please feel free to reach out to Manager Tine Højlund Andersen at +45 2071 2820.

Deadline for submitting your application is June 10th 2018.

We look forward to receiving your application.

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About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions.
LEO Pharma is headquartered in Denmark and employs around 5,300 people worldwide.
For more information, visit www.leo-pharma.com.
Application deadline: 10/06/2018

Location: Ballerup, Greater Copenhagen, DK

Job type: Permanent

Working hours: Full-time

Contacts: Tine Højlund Andersen
Mobile: +45 20712820