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Clinical Trial Administrator

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

  • Manage administrative work ensuring that the CROs maintain a complete and accurate Trial Master File and organized shipment of the final QC checked Trial Master File (TMF) at the conclusion of the trials
  • Perform Quality Control of the final TMF and assure administrative archiving of the TMF
  • Responsible for set up and maintenance of the Sponsor Oversight File in accordance with the SOPs
  • Proactively perform Sponsor Oversight File Quality Control to ensure accuracy and completeness and subsequent Quality Assurance audit resolution
  • Initiate collaboration with other functions to collect relevant documentation, in accordance with the SOPs
  • Serve as a main contact and/or liaison for the CROs for regulatory documents, CRFs, and other pertinent administrative matters, under the supervision of the Clinical Trial Manager
  • Facilitate the review of the essential document package prior to trial drug release
  • Coordinate the collection, review and tracking of all key clinical trial documents required for the Clinical Trial Report Appendices or Submission Packages (e.g. FDF, CVs.)

Clinical Trial Management

  • Schedule and coordinate internal Clinical Trial Team meetings, materials and agendas
  • Record and disseminate decisions and actions
  • Assist in trial set-up, planning of investigator meetings, face to face meetings, and presentations, etc.

Financial Management

  • Coordinate receipt, review, and tracking of assigned clinical trial invoices to ensure timely approval

Process Improvement

  • Participate in the development of department processes and best practices, including review of SOPs and development of standard reports, templates and/or forms related to the CTA job function 

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.

Personal skills:

  • Ability to work collaboratively across multiple functions within the organization
  • Demonstrated ability to prioritize and manage multiple tasks/projects simultaneously
  • Excellent written and verbal communication skills
  • Highly organized and detail-oriented, with excellent administrative skills
  • Strong interpersonal skills

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.

Unique Human Capital A/S
T +45 7020 6700
/ /
cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
/
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland