Clinical Trial Assistant

Join an international drug and device development consultancy and contribute with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

KLIFO Clinical Operations Solutions (COS) ensures operational and strategic advise and support to our clients with tasks of varying complexity. In our Global Documentation team, 5 highly skilled CTAs/eTMF managers work at our offices in Denmark and Germany managing the TMFs, Clinical Trial Management Systems, study documentation and other administrative tasks to support management of global clinical phase 1-3 studies and medical device studies. In addition we also provide work from clients offices with TMF management and document oversight and support to sponsor teams if required.

In the role as Clinical Trial Assistant, you’ll contribute by:

• Supporting the study team in the filing process and guiding in optimal setup of the TMF including preparation and review of relevant plans
• Setting up and maintaining the TMF and Investigators Files
• Performing periodic QC review and completeness check of the TMF
• Supporting the Project Manager and the Clinical Research Associates in the management of clinical trials
• Managing shipment/retrieval of study materials
• Supporting the Project Manager in meeting organization

Your background and qualifications:

You have a positive, proactive, flexible and self-driven personality and like to work in the consultant environment with a variety of tasks. In addition, you are service minded and a collaborative team player with solid planning skills, attention to detail and is fluent in English, both spoken and written.

Furthermore, you have:

• Preferably a minimum of 2 years in a similar position in the pharmaceutical industry/CRO. Candidates within Business Administration, Librarian or equivalent will also be considered
• Possess experience in management and filing of clinical trial documentation according to industry standards
• Understand regulatory requirements, guidance’s, and industry standards that govern TMF practices
• Possess excellent knowledge of GCP guidelines, medical terminology and clinical trial processes
• Preferably have knowledge about the Veeva clinical vault system (eTMF and CTMS)
• Ability to work independently without supervision of a colleague

Why join KLIFO?       

• Join an organisation where we value people and their expertise as the greatest asset
• Enter a flexible workplace with a culture based on trust, transparency and respect
• Work with some of the most experienced and dedicated colleagues in the life-science industry
• Contribute with your expertise across different therapeutic areas
• Develop tailor-made solutions based on cross-disciplinary collaboration
• Cultivate successful relationships with our clients
• Be part of an organisation that sees knowledge-sharing as the road to success

Share your application

Share your application with us at moc.ofilk@boj marked “Clinical Trial Assistant” no later than 28 February 2023. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Lykke Oldenburg, Team Manager, Global documentation at moc.ofilk@grubnedlo.ekkyl or +45 44422931 for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).