TMF Assistant

Looking for a motivated assistant to join our Clinical Reporting Department team and support our Trial Master File Archive efforts In this role, you will work closely with our team to maintain and organize critical documents related to clinical trials, as well as assist with various reporting tasks. If you have a strong attention to detail, excellent organizational skills, and a desire to contribute to cutting-edge clinical research, we want to hear from you 

Apply today and join us for a life-changing career

The position

The position offers a unique opportunity to work with archiving and document handling in order to support our drug development projects. The job also gives opportunities to optimize processes and implement digitalisation to benefit our global organisation.

As an assistant in the Clinical Reporting Department working in the Trial Master File Archive, your primary responsibility will be to maintain and organize critical documents related to clinical trials. This includes archiving Trial Master File documentation in both electronic and paper formats, collaborating with stakeholders in global affiliate offices to ensure accurate archiving, and supporting the organization with inspections and audits as needed. 

Your main tasks will include:
• Ensuring that shipments of paper TMF material from Affiliates are received, indexed in a global database, and delivered to our central archive
• Supporting Clinical Publishing and Transparency colleagues with document and mailbox related work tasks whenever necessary 
• Supporting, training, and coaching student assistants employed in the TMF Archive
• Engaging in projects developing and implementing digital solutions for archiving
• Training Medical Writers, Affiliates, Trial Management, and other colleges in our archiving processes

This is a critical role in ensuring the accuracy and completeness of clinical trial documentation, and requires a strong attention to detail, excellent organizational skills, and the ability to collaborate effectively with stakeholders across the organization.

Qualifications

Our ideal candidate should have an administrative background with at least 2 years of experience in archiving documentation in electronic systems, as well as experience working in either the pharmaceutical or publishing industries. 
 
Our preferred candidate should:
 
• Have extensive and broad experience with archiving electronical files and paper documentation
• Be a fast learner with an eye for detail, and able to quickly pick up new software skills
• Be flexible and structured, and able to thrive in a fast-changing work environment while maintaining high standards of accuracy, quality, and customer service to stakeholders
• Be proactive, capable of working independently, and being able to prioritize your own tasks, while at the same time being an active contributor to the success and harmony of the entire team
• Be a skilled communicator who is fluent in both written and spoken English

As a person, you have a high-quality mindset and take pride in delivering on your deadlines. You work well independently, although are also be motivated to cooperate with colleagues and stakeholder across the functions and departments. With structured approach to tasks, you maintain an overview - even in a changing environment where priorities can change quickly. Personal drive, energy and a positive attitude are key to thrive in this role.

About the department

The position is based in the Clinical Publishing, Transparency and Archiving Department located in Søborg, Denmark, where we are a team of 15 dedicated colleagues. We share an interest in supporting our drug development projects with our specific areas of expertise.