Senior TMF Lead

CSL

10d•Hybrid

About The Position

Every clinical trial CSL runs depends on a documented, defensible record of how it was conducted — the Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they need to know that a study was run to standard, from first patient in to final archive. Get the TMF right, and inspections go smoothly, submissions move forward, and study teams can focus on the science instead of scrambling for documentation. Get it wrong, and everything downstream slows down. We're looking for a Senior TMF Lead to take day-to-day ownership of that record across our full therapeutic portfolio — not as an administrative function, but as a genuine operational discipline with its own standards, technology, and continuous improvement agenda. You'll work closely alongside the Associate Director as a trusted partner on project management and TMF Operations standards, including people management, processes, and systems.

Requirements

Significant relevant clinical research (or related) experience in the pharmaceutical industry, with substantial hands-on experience building, setting up, and maintaining Trial Master File infrastructure.
Solid working knowledge of the regulatory landscape for global submissions, including ICH GCP, FDA GCP regulations, and EU Clinical Trials Regulations.
A track record of managing vendor oversight and of working in a formal management capacity.
Comfort operating across cross-functional, multicultural, international teams, and the judgment to make sound calls on complex, sometimes ambiguous, regulatory and operational questions.
Strong written and oral communication skills, with the interpersonal range to work independently and as part of a team.
Practical fluency with MS Word, PowerPoint, Project, Excel, and TMF-related applications — hands-on experience with Veeva Vault or another eTMF platform is particularly valued.
An undergraduate degree in life sciences, pharmacy, or another health/medical field is preferred; equivalent clinical research experience and relevant certifications (for example, an RN diploma/associate degree or certified medical technologist credential) will also be considered.

Nice To Haves

Experience implementing and maintaining clinical applications as a business user
KPI reporting
Process development or writing procedural documentation
Experience leading teams through change or a diverse range of working styles

Responsibilities

Provide oversight and hands-on management for a team supporting TMF operations across all of CSL's therapeutic areas.
Develop and implement TMF oversight processes, support study teams with TMF tools, and drive updates to TMF-related processes and standards.
Oversee TMF technologies, eTMF enhancements, reference model updates, templates, tools, training, and continuous improvement initiatives aligned with industry best practices.
Manage External Service Provider (ESP) performance to ensure TMF deliverables are achieved within quality, cost, and timeline expectations.
Support internal and external inspections and audits by providing TMF expertise, facilitating document retrieval, and addressing findings.
Establish, monitor, and report TMF metrics and KPIs to demonstrate inspection readiness and TMF completeness across the portfolio.
Build and maintain strong relationships with global stakeholders, fostering collaboration, communication, accountability, and customer focus.
Support study teams with TMF process and system escalations while driving efficiencies, quality improvements, and cost reduction initiatives.
Ensure compliant archiving of paper and electronic TMFs, including vendor coordination and adherence to TMF plans, SOPs, and retention requirements.
Support eTMF business ownership, system requirements, process capabilities, and TMF transfer activities as needed.
Lead, coach, mentor, and develop TMF staff; support recruitment, resource planning, performance management, and succession development.