Clinical Trial Assistant (CTA), Munich, Germany

Join an international drug 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 advice and support to our clients with tasks of varying complexity. In our Global Documentation team, 4 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. In addition we also provide work from clients’ offices with TMF management and document oversight and support to sponsor teams where 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
• Supporting the Project Manager in meeting organization
• Managing shipment/retrieval of study materials

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:

• Preferably have 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 good knowledge of GCP guidelines, medical terminology and clinical trial processes
• Preferably have knowledge about the Veeva Clinical Vault system (eTMF and CTMS)
• Have the ability to work independently without supervision of a colleague
• 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  marked Clinical Trial Assistant (CTA) no later than 6 March 2024. Kindly state how you heard about this position. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Sibylle Gaupels , Team Manager COS at or +49 160 94143935 or to Sara Hedman , Sr Director COS at or +46 708 708084 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).
For information on KLIFO’s processing of personal information see

Location

Employment

Full-time

6 March 2024

Contact

About KLIFO

• Offices in Denmark, Sweden, Germany and The Netherlands
• Headquarter in Glostrup, Denmark

KLIFO is a leading North-European drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies.

We provide end to end solutions and support our clients with strategic advice and operational support across therapeutic areas and disciplines.