TMF Manager

Who is our client?

They are a growing pharmaceutical company, where they value the contribution of all their people. By working collaboratively, they strive to improve the lives of the patients they serve. An innovative company who think outside the box, collectively working together are all fundamentals of their culture.

They have a successful track record of developing and launching new medicines for the European market. As they continue to grow, they have a strong pipeline of clinical projects across different therapeutic areas.

As a Trial Master File Manager, this is a crucial position where you will have the oversight of the studies and preparation for any potential audits/inspections. In this role you will have a high level of responsibility and technical expertise inside the clinical team.

You will manage document control processes and systems for GCP activities in compliance with internal procedures and policies as well as regulatory requirements. In this role you can look to develop your skillset as you will have key strategic input and have the opportunity to develop a global TMF structure.

Other responsibilities will include:

• Providing TMF business guidance to study teams, functional areas and document users. Oversees the TMF migration process from CRO eTMF system to eTMF system for Record Management/business group. Finalisation of TMF plan and specification for numerous studies Drive TMF finalisation TMF start up activities for any new studies assigned TMF SOP review and process improvements Support administrative tasks as assigned by the clinical operations head

In this role you will need excellent knowledge of ICH-GCP guidelines and FDA/EMA/PMDA regulations. Other requirements include:

• Excellent working knowledge of clinical study documentation Excellent IT proficiency with ability to easily learn new technologies Ideally Veeva Vault proficiency Ability to understand technical, scientific and medical information Excellent oral and written communication skills and ability to adjust communication to different target groups 

To be successful you will be able to effectively multi-task, be proactive and self-motivate whilst being a team player and having strong attention to detail.

If you have the right experience and skills and are excited by the role, please apply.

This is a full time hybrid role with 2 days a week in the office in AMSTERDAM. My client will also consider a contractor / freelancer for this role.