TMF Lead II - FSP - US

About the role

The TMF Management team is seeking a TMF Lead II to manage and support the study Trial Master File (TMF) for all sponsored studies. This role requires strong experience in heavy metrics reporting and KPI development.

Responsibilities

• Manages and supports the study TMF right from the study set up to the closeout, including the transfer of the TMF.
• Maintains and assesses the overall TMF Health (quality, completeness, and timeliness).
• Delivers technical expertise on the electronic TMF (eTMF) and supports Inspection Readiness goals in compliance with ICH/GCP guidelines.
• Provides process, control, coordination, and approval of clinical trial documents.
• Coordinates with key study personnel to establish expectations, requirements, and deliverables in line with ICH and to support scope build.
• Oversees the planning, set-up, maintenance, Quality Control (QC), and closure of the study TMF for clinical studies, in accordance with agreed TMF processes (Fortrea or sponsor SOPs).
• Monitors and escalates missing, incomplete, incorrect, inaccurate artifacts to the appropriate study team members.
• Maintains the TMF in a state of audit/inspection readiness by completing the Initial matching of Index with Expected Document List (EDL) update for required documents and count, in collaboration with leads from each functional group within the study.
• Ensures ongoing "real-time" EDL maintenance updates are maintained by each functional group per assigned study.
• Oversees timely kick-off of TMF Review Workflows on or before 25th Day of the Milestone Release.
• Maintains awareness of study events and the associated documentation requirements.
• Contributes overall client satisfaction.
• Maintains an understanding of applicable regulatory requirements.
• Contributes to business development opportunities.
• Acts as the Point of Contact for Technical Issues faced by other TMF DC roles (e.g.: Classifiers, Reviewers) during maintenance of the TMF in the UCV system.
• Performs training and mentoring as required.

Qualifications

• BS/BA degree in related discipline and a minimum of six-seven years of related experience; or, MS/MA degree in related discipline and a minimum of three years of related experience; or, Equivalent combination of education and experience.
• Minimum 7 years’ experience working in a clinical research environment.
• 5+ years experience in TMF.
• Clear understanding of GCP and ICH guidelines.
• Knowledge of Regulatory/Clinical document requirements.
• Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.