Trial Master File Specialist (TMFS) II

Company Description

Medicine moves forward here. So will you.

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

Job Description

• Assists with set up and maintenance of the Trial Master File (TMF). 
• 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. 
• Upon study closure, assists in reconciliation of TMF; ships files to client, if agreed, and prepares TMF for archiving. 
• Tracks and performs quality check of documents using internal systems and ALCOA+ principles. 
• Prepares study team reports or updates regarding status of TMF as required. 
• Supports preparations for study specific audits, attends in-house project audits if required, takes part in analysis of received audit report. TMF Specialist II can also propose and oversee completion of Corrective and Preventative Action Plan with respect to all TMF aspects of the project. 

Qualifications

• TMF maintenance and quality check experience
• ALCOA Principles.
• Administrative work experience, preferably in an international Clinical Research setting. 
• Proficiency in Excel. 
• Ability to take over responsibility for TMF quality; follow up on topics independently.
• Very good English oral and written communication skills.

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.