Senior Clinical Trial Administrator

Found in: Talent DK C2 - 3 weeks ago

Copenhagen, Denmark Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Fortrea is currently seeking a pro-active Senior Clinical Trial Administrator  to join our expanding team in Denmark.

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.

Minimum Required:

2 years experience on a similar position

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

Good organizational and time management skills

Good communication skills, oral and written

Fluent in Danish language and in English, both written and verbal.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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