LEO Pharma

Clinical Support Specialist (CSS/CTA)

Would you like to play a key role in the development of our growing portfolio together with a professional and expanding team of Clinical Support Specialists (CSS) and are you an experienced CSS/Clinical Trial Administrator? If so, we have just the perfect match for you in our Clinical Administration team.

LEO Pharma has set an ambitious goal to become the world leader within dermatology with an exciting 2025 strategy and a strong development pipeline – well balanced with many projects in early-stage as well as in late-stage development.

You add value to Clinical Trial Specialty deliverables

As a CSS you are an integral member of the clinical trial teams supporting the conduct of LEO Pharma’s clinical trials. You will be involved in the entire lifecycle of a clinical trial from clinical trial start-up through conduct and to clinical trial reporting and Trial Master File archiving. The CSS supports the entire trial team with the specialised deliverables in ensuring the success of a clinical trial.

Your main responsibilities will be:

  • establishing and maintaining the Trial Master File (eTMF) together with the trial team and/or the CRO
  • to ensure quality and completeness of the eTMF
  • performing quality control of the final eTMF and ensure archiving
  • 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 be an essential member of the clinical trial teams and responsible for specialty deliverables and support to the team members


Qualifications

You have solid skills in handling and prioritising many daily tasks. You thrive in an international environment where stakeholder management is a key requirement. Our ideal candidate has a strong customer service mind-set, excellent collaboration skills, team spirit, and a good sense of humour.

Furthermore, the successful candidate has:

  • Knowledge of ICH/GCP
  • A Bachelor’s degree as a minimum
  • Proficiency in both written and spoken English
  • Ability to work structured and consistently with many varied tasks each day
  • Ability to keep focus on details while remaining overview
  • Is self-motivating, proactive and has a strong quality mindset
  • Knowledge, flair and interest for working in Document Management systems as well as Trial Management systems
  • Experience with MS Office Package
  • Knowledge of eTMF systems, such as Veeva Vault is considered an advantage
  • Previous experience in working as CSS (CTA/Clinical Trial Administrator) is considered an advantage


Global Clinical Operations – your new work place

Global Clinical Operations is responsible for all LEO Pharma sponsored clinical trials from phase I-IV. In Clinical Administration you will have 19 colleagues, placed in two countries, who are dedicated and provides outstanding support to LEO Pharma’s clinical trials.

We look forward to receiving your application.

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Application deadline:

25/10/2019

Location:

Ballerup, Greater Copenhagen

Contacts:

Nete Ahlgren-Møller

Mobile: +45 3117 2260

Company homepage:

http://www.leopharma.com

Office address: