Clinical Support Specialist (CSS/CTA)

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Ballerup

Support to LEO Pharma’s Clinical Trial portfolio


LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. 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 we have just the perfect match for you in our Clinical Administration team.

In Clinical Administration you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job


As a Clinical Support Specialist, you are a member of the clinical trial teams providing support and playing a key role for the success of 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 Trial Master File archiving.

Your main responsibilities:


  • Establish and maintain the Trial Master File (eTMF) together with the trial team and/or the CRO
  • Prepare the Trial Master File management plan in collaboration with the trial team and/or CRO
  • Drive the Completeness Check to ensure high quality and completeness of the eTMF
  • Ensure timely archiving of the final eTMF
  • Drive the Investigator Trial File process to ensure timely delivery at trial sites
  • Ensure essential clinical documents meet technical requirements for electronic submission to authorities
  • Assist with inspection/audit related activities e.g. preparation or correction action plans
  • Address TMF questions pertaining to how documents are correctly filed, correctly named and to good documentation practice in general

Furthermore, you should maintain up to date knowledge of TMF DIA Reference model 3.0 and assist and engage in relevant projects in the department as needed.

Your qualifications:


  • Experience in working as a Clinical Support Specialist (Clinical Trial Administrator) or equivalent
  • A Bachelor’s degree as a minimum e.g. in Life Science
  • Previous experience in Veeva Vault TMF is preferred
  • Strong knowledge of ICH-GCP guidelines related to clinical document management
  • Understanding of the clinical trial process
  • Ability to keep focus on details while maintain an overview
  • Proactive approaches to problem solving with strong decision-making capabilities
  • Experience with MS Office Package
  • Proficiency in both written and spoken English


Furthermore, you have solid skills in handling and prioritizing many daily tasks. You are self-motivating, proactive and have a strong quality mindset and 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 humor.


Your new team


You will join a dedicated international team of 15 Clinical Support Specialists and 3 HCP Payment Coordinators, and 1 Archivist based in DK and US. We have an open and honest atmosphere and value the importance of a solid onboarding by prioritizing supporting new colleagues with both a mentor and a buddy. This to help you get well integrated in your new function.

Join our mission to help more people achieve healthy skin


Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application


If you have questions, please do not hesitate to contact Nete Ahlgren-Møller, Manager of Clinical Administration 2 at + 45 3117 2260 . The deadline is 27-01-2021.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Ballerup.

Jobbet er oprettet på vores service den 5.1.2021, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Ballerup
  • Onsdag den 27. januar 2021
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