Overview
Reference Number: JO-2101-460455
TMF Manager
Rate: Negotiable
Job Type: Permanent
Location: Welwyn Garden City
TMF Manager
Hertfordshire
Global Pharma
Competitive Salary + Benefits
We have an exciting new opportunity for an experienced TMF Manager to join a global pharmaceutical company based in Hertfordshire. You will be joining a globally renowned company who invest heavily in the development of their staff.
This is a pivotal role in which you will provide strategic oversight of TMF processes and procedures. You will be responsible for implementing and training effective TMF processes across the whole business and to external stakeholders.
Responsibilities;
– Overseeing the daily global management activities relating to clinical study Trial
Master Files (TMF)
– Oversight for Quality Control eTMF/TMF review process
– Ensuring regulatory inspection-readiness and compliance with applicable laws and
regulations
– Work collaboratively with global teams
– TMF reporting and serve as a subject matter expert in TMF Operations
Experience Required;
– Demonstrated experience in the pharmaceutical industry, in Document Management, TMF
– Proven experience with Electronic Clinical Document Management and eTMF systems
– Knowledge of eTMF requirements and technologies to support document collection and archiving.
– Must have broad understanding of the clinical development process
– Life Science Degree
This is a permanent role offering a competitive salary and excellent benefits. At present, this role is fully remote however there will be an expectation for a presence in the office 2-3 days per week when it is safe to do so.
If this role is of interest, please call 0118 959 4990 or email your cv to George.Danchie@cpl.com
