Clinical Trial Assistant - Denmark

Fortrea; Søborg; On-site; DKK 357,000 - 469,000; Full time

Job summary

Fortrea is seeking a Clinical Trial Administrator to join our team in the Copenhagen area. The role focuses on handling study documentation, tracking activities, coordinating meetings, and supporting project teams with administrative tasks to ensure timely, high-quality data delivery.

The ideal candidate will be fluent in English and Danish, have at least 1–2 years of administrative experience in clinical research or related fields, and be proficient with Microsoft Office and CTMS systems.

Qualifications

• Diploma – Associate degree or equivalent.
• 1-2+ years of administrative experience in Clinical Research or related field may be considered.
• Minimum of 1 year administrative experience or equivalent training.

Responsibilities

• Document and track study activities using forms and project systems.
• Assist in preparing study materials per SOPs.
• Take minutes for sponsor/internal teleconferences as requested.
• Set up and maintain tracking systems for study supplies.
• Maintain the Project Directory and TMF documentation as assigned.
• Provide support for Investigator Meetings and meeting coordination.
• Coordinate communications with sponsors, sites, and internal teams.

Skills

English fluent

Danish fluent

Microsoft Office

Communication skills

Education

Associate degree

Tools

CTMS

Microsoft Office Suite

Job description

This role is for upcoming future opportunities that may arise at Fortrea.

Copenhagen area.

Job Overview:

The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the CTA shall reflect their experience, and level of contribution which they can make to the project. The CTA performs study-related tasks as required by the department, including (but not limited to): communicate with project team members regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required. Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable.

Summary of Responsibilities:

• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
• Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.
• Complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
• Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies.
• Maintain the Project Directory.
• Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
• Provide support to project team (e.g., proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.).
• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable.
• Audit and CAPA tracking.
• Set up and maintain clinical investigator files and documentation.
• Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
• Coordinate and plan study supply shipments with vendors.
• Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery.
• Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders).
• Generate reports as needed, for example CTMS site contact information list.
• Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
• General communications to sponsors, sites and internal team members via electronic mail or courier or telephone.
• Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Diploma – Associate degree or equivalent.
• In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• English and Danish - fluent.

Experience (Minimum Required):

• Minimum one (I) year administrative experience or equivalent training.
• Good oral and written communication skills.
• Good organizational and time management skills.
• Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint).
• Aptitude for handling and proof-reading numerical data, some spreadsheet software competency.
• Good typing skills.
• Good spelling and proof-reading skills.
• Ability to operate standard office equipment (e.g., fax, copier).
• Works efficiently and effectively in a matrix environment.

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