Clinical Trial Administrator

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 Administrator (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.
  

Application
We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. We encourage you to apply before end of business on 2nd June 2024.

If you have questions about the role before applying, please reach out to hiring manager Bruno Santacruz at [email protected]. Please apply only using the application system. Do not submit CVs or applications to the provided e-mail of the hiring manager as these will not be considered.

We thank you for your interest. Please read our Applicant Data Privacy Notice carefully here.

Hybrid
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Danaher

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Placering
Bronshoj, Denmark, state: , cityCountry: Bronshoj, Denmark