Trial Master File Lead

TFS HealthScience•Auburn, ME

8h•Remote

About The Position

As part of our CDS Therapeutic area / Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Lead is responsible for organizing, maintaining and overseeing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, PM delegation and coordinating main tasks under TMF Business Line and may act as Line Manager for TMF Associates.

Requirements

5 and above years of proven relevant experience in Clinical Trials with TMF management including oversight and quality control.
Deep Knowledge of GCP/ICH guidelines.
Strong understanding of the impact of the TMF on the Study management.
Strong written and communication skills and demonstrate ability to communicate and coordinate within the group of TMF stakeholders.
At least 1 year of proven people management.

Responsibilities

Create the Study TMF EDL in cooperation with PM (Project Manager) and study team.
Create first draft of TMF Plan, implement changes after review, generate final version and distribute final version to the study team.
Create TMF at Trial, Country and Site Level (paper TMF).
Control if the Electronic Trial Master File (eTMF) at Trial, Country and Site Level was properly created by Clinical Business Administrator (CBA) team when TFS system is used.
Inform the study team that TMF is created and ready for document upload for eTMF or submission to paper TMF (pTMF).
Actively follow up study team is submitting documentation following the process described in The TMF Plan and that TMF the TMF is always audit and inspection ready.
Set up the Investigator’s File as directed by Clinical Research Manager (CRM) and forward the CRM a tracker of all document sections within the ISF. This activity may be delegated to TMF A and/or Project Management Associate (PMA) depending upon study needs.
Actively collaborates in the training to study Team regarding the TMF workflow and management.
Act as contact person for study team to support on TMF doubts or TMF issues and support study team to ensure TMF is always inspection ready.
Maintain and follow up TMF status, identify areas with missing documentation and inconsistencies and follow up with the study team finding’s resolution.
Perform Quality Check of each document before filing in TMF and follow up issues until resolution.
Perform Quality Check of each uploaded document after filing in eTMF and follow up issues until resolution.
Responsible to create and maintain paper TMF (pTMF) tracker and generating reports for eTMF.
Generates metrics supporting TMF completeness and accuracy.