Assistant, Trial Master File

Company Description

We are  Ergomed group, a specialised mid-size  service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.  

Ergomed provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.  

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.  

Come and join us in this exciting journey to make a positive impact in patient’s lives.   

Job Description

This is a great entry-point for detail-oriented professionals looking to launch a career in clinical research. As a TMF Assistant, you will become the guardian of study integrity, mastering the "gold standard" of clinical documentation.

About the Role:

• Launch Your Career: Perfect for new starters to learn the lifecycle of clinical trials through hands-on TMF management.
• Become a Quality Specialist: Master ALCOA+ principles and SOP compliance to ensure every document is inspection-ready.
• Work Globally: Join an international team, utilizing your English and MS Office skills to coordinate vital project records.
• Dynamic Coordination: Move beyond basic admin by multitasking across diverse projects and attending key team meetings.
• Grow into Leadership: Develop the expertise needed to support audits and CAPA plans, building a strong foundation for future growth.

Qualifications

• High school diploma or equivalent or adequate experience in the field of clinical research
• TMF maintenance and quality check ALCOA Principles
• Administrative work experience, ability to plan, multitask and work in a dynamic team environment
• Excellent English oral and written communication skills
• Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)

Additional Information

Why Ergomed  

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  

We offer:  

• Training and career development opportunities internally   

• Strong emphasis on personal and professional growth  

• Friendly, supportive working environment  

• Opportunity to work with colleagues based all over the world, with English as the company language  

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed could be a great company to join!   

• Quality  

• Integrity & Trust   

• Drive & Passion   

• Agility & Responsiveness   

• Belonging  

• Collaborative Partnerships   

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.