Clinical Trial Administrator

at  Radiometer

Do you want to support Radiometer’s vision to improve global healthcare with reliable, fast, and easy patient diagnoses? Do you have experience with electronic trial master files (eTMF) in clinical studies and a flair for structure and good documentation practices? Then you could be our next colleague in the team of Clinical Operations.
We offer a newly created position as Clinical Trial Assistant (CTA). You will be the first dedicated CTA in the team and will work with 11 international clinical study managers to support compliance and documentation requirements for our international clinical study programs.

The Clinical Trial Administrator is responsible for:

• Driving eTMF quality and completeness:

By developing study-specific TMF Management Plans, performing ongoing reviews of the TMF quality, ensuring the TMF is inspection-ready through the course of the study and collaborating with clinical study managers and other stakeholders to address completeness and quality gaps, among other activities.

• Driving the expansion of efficient and scalable eTMF processes, systems, and initiatives:

E.g., by supporting the development or improvement of processes and tools that support the management of TMFs or generating and maintaining training material concerning the use of the eTMF.

• Good Documentation Practices (GDP) ambassador:

By leading with example on good documentation practices and providing other colleagues guidance on such standards as defined by GCP and Health Authorities.
You will also train and coach a junior CTA colleague being recruited in parallel to this position, creating or supporting effective processes, roles, and communication between you.
Our team, Clinical Operations, is part of the Clinical & Medical Affairs (CMA) department located in Brønshøj, Denmark. You will have the opportunity to work with global teams of colleagues located in Europe, North America, and Asia.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Min 2 years’ experience in clinical study operations in a similar role
• Experience with at least one electronic TMF system. Experience with Veeva® eTMF will be considered an advantage.
• Ability to create effective working relationship with internal and external stakeholders, ideally with experience from international settings and teams.
• English is our company language, so a good written and spoken command of it is necessary.

• Driving eTMF quality and completeness