TMF Record Specialist

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

Your key responsibilities:

To provides and maintains oversight and guidance related to TMF activities throughout the course of the trial,
To collaborate closely with the core trial team to create, implement and maintain the list of trial-specific expected records
Responsible for the planning, tracking, formal QC and filing of all TMF trial level records according to internal and external standards and also to initiate the close out of the TMF.
To share the status to the core trial team on the completeness, quality and timeliness of the TMF during the entire life cycle of the trial.

Your role:

The TMF Record Specialist is a member of the core trial team and is responsible to provide operational expertise to the core trial team, oversees the implementation of the (Trial Master File) TMF strategy for the trial and supports the core trial team in all aspects of TMF management and in inspections or audits.

What you should bring to the team:

Knowledge of ICH-GCP
Good Documentation Practice and document filing requirements
Conflict management
Negotiation
Team player
Excellent English communication skills in writing, speaking and reading.
Ability to prioritize
Ideally 2-5 years documentation management experience

Please note you will need to be based in the Netherlands when working in this role (fully remote working is not possible) – and this is not a freelance assignment.