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Clinical Trial Associate

IO Biotech is a young biotech company developing novel, disruptive immune modulating anti-cancer therapies. IO Biotech is growing at a fast pace and would therefore like to expand the team with an experienced Clinical Trial Associate.

As Clinical Trial Associate at IO Biotech you will be responsible for providing administrative and operational support to Clinical Operations to ensure efficient and effective conduct of clinical studies to industry and company standards while meeting study requirements and targets.

With direct report to the Senior Clincial Trial Manager

Your main tasks are:

  • Support Senior Clinical Trial Management and Operational Study Team in the execution and delivery of studies
  • Assist in managing contracts with sites and vendors
  • Draft and/or assist with the preparation of trial-related documents, tools and templates
  • Track and maintain study logistic information, systems and tools
  • Maintain and manage appropriate study documentation in accordance with regulations and timelines
  • Provide support from study start-up through study close-out
  • Develop naming convention for the Trial Master File (TMF)
  • Track and reconsile essential documents for TMF according to ICH GCP and company procedures and ensure quality of documentation and archiving
  • Keep database, tracking systems and tools up to date in order to support budget payment and contracting processes
  • Actively take part in Study Team meetings and be responsible for minutes
  • Be in charge of administrative tasks concerning setting up Investigator meetings
  • Provide administrative support to CMO/group as assigned
  • Other activities as necessary 

Your qualifications are 5 – 7 years of relevant experience, including at least 5 years as Clinical Trial Associate, preferably within oncology and/or haematology. You have in-depth knowledge of industry standards and best practices in clinical data management and ICH GCP. You have strong communication skills and are fluent in English, both oral and written. You have experience with Microsoft Excel, Word, PowerPoint, Outlook, Sharepoint/BOX or MS Project. 

You have a Master’s Degree in Pharmacy, Library Science, or have an education as a Pharmaconomist or the like. 

As a person, you are able to work as part of a team as well as independently. You display a high level of commitment to service and your are process-oriented while paying a high degree of attention to detail. You have a sense of urgency balanced with good judgement, you are flexible and you are passionate about your work.

IO Biotech offers the right candidate the possibility of joining a young and growing company in which there is plenty of space to develop both professionally and personally while having a large degree of input into the functions of the position.

Travelling: Very little travel (if any) can be expected

Domicile: IO Biotech is located in Copenhagen Bio Science Park (COBIS) in central Copenhagen.

For more details about the job or the company, 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.

Unique Human Capital A/S
T +45 7020 6700
/ /
cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
/
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland