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Hobson Prior are looking for a Senior CTA to join a biopharmaceutical organization on a permanent basis located in Copenhagen. Our Client is focused on developing a first-in-class immunomodulating cancer vaccine that will form the basis of cancer combination therapies.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will provide support to the study team during the execution and delivery of the study.
- Assist the study team with administrative tasks as required.
- Support the start-up, execution, and close-out of studies.
- Maintain compliance with established SOPs, ICH-GCP, and other applicable regulatory requirements.
- Assist the clinical trial team and the CRO in developing the TMF Index and TMF Plan.
- Maintain a quality control program for documents based on the TMF plan and analyze trends.
- Ensure that TMF documents are available and complete.
- Ensure TMFs comply with SOPs, GCPs, regulatory requirements, and national/regional requirements.
- Managing trial-specific documents with clinical trial teams and CROs on a daily basis.
- Educate the clinical trial team and CROs about learnings, successes, and setbacks.
- Assist in drafting, preparing, and maintaining trial-related documents, tools, and templates.
- Maintain, develop, and track study logistics information, tools, and systems.
- Maintain accurate and timely tracking of invoices to vendors.
- Organize, schedule, and take minutes of meetings, both internally and externally, as needed.
- Organise Investigator meetings or other meetings by handling administrative tasks.
- A variety of other duties may be assigned as needed.
- Communicate effectively and write and speak English fluently.
- An excellent understanding of Microsoft Office
- A minimum of 3-5 years' experience as a clinical trial assistant
- Extensive experience in the use of electronic TMF systems and electronic document management systems.
- Understanding of clinical trials and regulatory submissions. Knowledge of regulatory requirements for clinical trials (ICH/GCP).
- An oncology or haematology background is preferred.
- Degree of Associates/Bachelor's or equivalent preferred.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.