Why Most TMF Leads Struggle With Oversight (And How to Fix It)

TMF Elite — this is one of those episodes you bookmark, replay, and take notes on.

Welcome back to the TMF Daily Podcast. I’m your host, Nicole Palmer, and today’s guest isn’t just managing Trial Master Files, he’s architecting them. Building systems. Raising standards. Delivering inspection-ready quality without the chaos.

If you want real, actionable excellence in TMF leadership… lean all the way in.

I’m joined by Evan Peterson, a clinical research leader with 20 years of experience across the full spectrum of clinical operations. And when I say full spectrum, I mean it.

Evan has been a:

-Clinical Data Coordinator

-CRA

-Site Regulatory Coordinator

-Vendor Project Coordinator

-TMF Lead

That kind of résumé doesn’t happen by accident. It’s built through curiosity, discipline, and relentless growth.

And this isn’t someone who’s worked on a handful of studies. Evan has contributed to 200+ clinical trials across oncology, pulmonology, and infectious disease (including virology). This is lived experience — the kind you can’t fabricate and can’t shortcut.

In this episode, we break down the TMF Lead role at an elite level — not theory, not buzzwords, but what actually works in the real world.

We cover:

-The Day-1 standards every TMF Lead must set (and what’s non-negotiable)

-What world-class TMF leadership really looks like beyond industry talk

-The daily rhythms and disciplines that keep complex TMFs under control

-How to build inspection-ready systems instead of living in scramble mode

-The blind spots that quietly derail TMFs — and how elite Leads eliminate them early

-Balancing speed with quality without compromising integrity

-Leading CRAs, CROs, and vendors without micromanaging

-How to rescue a messy or behind TMF and assess how deep the problem goes

-The few KPIs that actually matter (and why most teams track the wrong ones)

-Training teams, shifting culture, and raising the bar fast

-Knowing when to escalate vs. when to fix internally

-What true TMF completeness feels like beyond metrics

-Handling resistance while standing firm on quality standards

-The mindset shift from TMF manager to TMF leader

And the one decision that can change everything for someone who wants to become an elite TMF Lead

If you work in TMF, clinical operations, quality, or trial leadership, this conversation will challenge how you think — and elevate how you lead.

🎧 Listen all the way through. Take notes. And if this episode levels you up, make sure you’re subscribed.

Welcome to the TMF Daily Podcast — where TMF Elite comes to get better.

Website: www.granularlevel.com

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