TMF Manager - UK (Remote)

TMF Manager - UK 

up to £45,000

I am pleased to working with a global CRO who are looking for a TMF Manager for one of their prestigious sponsor partners. With industry leading systems and site management tools they are constantly adapting to make work more manageable, flexible, and efficient for their staff. 

In this role you will be responsible for efficient and appropriate management of Trial Master Files (TMF) and other TMF related, inspection relevant documents from creation through archival in compliance with applicable SOPs, processes and study specific requirements for assigned trials according to established timelines.

Responsibilities:

Run and lead eTMF activities.

Manage a team of highly skilled CTAs.

Provide oversight of eTMF activities outsourced to CRO Partners.

Partake in active vendor management, including development and monitoring of KPIs in respect of eTMF and document quality. 

Work with the vendor to set up new studies.

Ideal Background:

Comprehensive understanding of TMF procedure, regulatory requirements and GCP

Extensive experience of clinical trial documentation and reporting

Good understanding of technical processes and PC environment including Microsoft suite of products

Understanding of the local and cross-national data protection legislation 

Advanced capacity to work both independently and in matrix team setting

Experience with project work or project management in a global, cross-functional multicultural and international matrix organization

Experience managing multiple tasks and projects within specified timelines and balance conflicting priorities

Excellent communication, organization and tracking skills

eTMF and paper filing experience 

Benefits

Fully remote, flexible working 

Consistent workload 

Competitive salary plus car allowance

This is one of the many roles I am currently recruiting for in the UK. For further information or to apply to this role then please get in contact with Paul Adam at RBW Consulting - 01293 364079/paul.adam@rbwconsulting.com