Trial Master File Specialist (TMFS)

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.   

TMF Specialist supports the management of project-specific Trial Master File (TMF) through the quality check, maintenance and filing of clinical records.

• Assists with set up and maintenance of the Trial Master File (TMF) for assigned projects 
• Serves as main point of contact for all TMF-related activities for assigned projects.
• Processing and indexing of project documents for the TMF in accordance with project-specific guidelines and relevant SOPs.
• Ensures that all project documents are maintained in accordance with relevant SOPs.
• Assists in TMF closure, transfer and archiving 
• Tracks and performs quality check of documents using internal systems and ALCOA+ principles.
• Attends project team meetings and training sessions on request and according to project and/or Sponsor requirements.
• Manages preparations for study specific audits, attends in-house project audits if required, takes part in analysis of received audit report.
• If requested by the PM/CTM, the TMF Specialist can also propose and oversee completion of Corrective and Preventative Action Plan with respect to all TMF aspects of the project.

• High school diploma or equivalent or adequate experience in the field of clinical research
• TMF maintenance and quality check ALCOA Principles
• Administrative work experience, preferably in an international Clinical Research setting 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)

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.