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Challenging position in an exciting biotech company
As Clinical Trial Administrator (CTA) you will join a dedicated team of professionals and become an important part of the Clinical Development staff of a progressive and innovative Danish biopharmaceutical company with a late stage pipeline. The company is based in Copenhagen and you will have direct report to VP Clinical Operations.
The position is newly established, and you will support the Clinical Operations Team in the day to day conduct of clinical trials. Primary responsibilities include tracking and maintenance of clinical trial documentation associated with the conduct of investigational clinical trials in accordance with FDA regulations, Good Clinical Practice (GCP), and company Standard Operating Procedures (SOPs). The CTA will support the Clinical Project Team by facilitating and recording Clinical Trial Team meetings as well as contribute to process improvement and knowledge-sharing.
Your main tasks are:
Essential Document Collection and Oversight
Clinical Trial Management
You have at least 2 years of clinical research experience (CRO, Pharmaceutical, Biotechnology and/or healthcare setting) and at least 1 year of experience with clinical trial essential documents in a clinical trial environment within the biotechnology/pharmaceutical industry. You are passionate about Trial Master Files and have solid experience working with both paper and electronic TMFs. You are proficient in MS Excel, Word, and PowerPoint and knowledge of MS Project is preferred. Having worked with implementation of Good Clinical Practice (GCP), ICH etc. is also favored.
You have a Master’s Degree in Library Science. You could also have a background as a registered nurse or similar. Most important is that you have experience as CTA.
The company offers a unique opportunity to influence your own work as well as your personal and professional development. It is a position in a company in development with an exciting pipeline and a positive and informal environment.
Travelling: 5 – 10 days a year
Domicile: Central Copenhagen
For more details about the job, please contact Research Consultant Jeanne Dederding, Unique Human Capital on M +45 28 74 58 71. All applications must be in English and are treated confidentially.