id: NDg5NTQ1OSA3

reference: 4895459

documentId: 4895459

connectionPointId: 7

lastModificationDate: 1540370469640

stillingsbetegnelse: Clinical Support Specialist

jobbeskrivelse:

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

LEO Pharma has set an ambitious goal to become the world leader within dermatology with an exciting 2025 strategy and a strong 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 part of the clinical trial teams in Global Clinical Operations. 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 of the trial master file. 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 will be:

• to be an essential member of the clinical trial teams and responsible for specialty deliverables and support to the team members
• responsible for establishing and maintaining the Trial Master File (eTMF) together with 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

 

Qualification

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 successful candidate will have:

• Previous experience of working as a CSS (CTA) in the Pharmaceutical Industry
• Knowledge of ICH/GCP
• A Bachelor’s degree 
• Proficiency in both written and spoken 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
• Experience with MS Office Package

Our ideal candidate has a strong customer service mind-set, good collaboration skills, team spirit, motivation to work with new challenges and a sense of humour.

 

Global Clinical Operations – your new work place

Global Clinical Operations in Ballerup is responsible for all LEO Pharma sponsored clinical trials from phase I-III. In Clinical Support Services you will have 20 colleagues, placed in two countries, who are dedicated to the CSS-role in our clinical trials.

We look forward to receiving your application.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR