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Trial Master File Expert

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England, United Kingdom The RFT Group Full time

Trial Master File Expert Our client is a young innovative clinical stage Biotech company with a strong development pipeline, now have approval for a new position for a Trial Master File (TMF) Expert within the Clinical Development and Operations group. There is flexibility for this hire to work remotely / from home office, with occasional meetings in their office.

Reporting to the Director of Clinical Development and Operations, this hire will manage TMFs, Sponsor Oversight File (SOF) and Archiving for all studies according to ICH-GCP and other regulatory requirements. This TMF Expert will work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced operational activities.

Serve as company point of contact for the migration study teams for TMF matters and liaise with the other TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure the migrated TMFs are inspection ready.
Indexing, Post-Migrating Remediation, changing the TMF to e-TMF, Auditing TMF, Meeting Metrics for documentation, doing QC Checks, Archiving.
QC of internal documentation, identifying missing documents and compiling tracking sheets in accordance with agreed processes.
Support project teams through (e)TMF and study document management, vendor management, assist with regulatory and ethics submissions.
Support key project management tasks including creation of project specific oversight plans, setting up project tracking tools, maintaining electronic filing system for all projects for example maintain a tracker of all country insurances.
Work closely with the Clinical Project Managers to organize and execute clinical trial activities.
Schedule meetings and manage travel arrangements.
Attend and participate in any company audits or regulatory inspections as required.

Bachelor of Science degree is preferred.
10+ years’ experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech or CRO industry working ICH / GCP guidelines.
Experience in QC, maintenance of trial tracking sheets and databases and of preparing documentation for archiving.
Proven ability to work under pressure to meet project deadlines.
Excellent communicator of technical and scientific information.
Proficient in Word, Excel and PowerPoint.

The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.

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