What You Are Actually Accountable For

Part of Clinical Project Management (PM) Training: What a Project Manager Owns.

About 2 minutes. Free, in your language, no account needed.

The trial runs whether or not you manage it

A clinical trial has a protocol, sites, a drug supply, a database and a sponsor who wants to know how it is going. All of that exists without a project manager. What does not exist without you is a single place where the state of the trial is known.

That is the job. Not doing the work at the sites, not writing the protocol, not monitoring. Knowing where the trial actually is, and making the decisions that keep it moving.

Three things that are yours

The plan. Milestones, dependencies, and a critical path that reflects reality rather than hope. If the plan is wrong, every decision made from it is wrong.

The oversight. ICH E6(R3) puts trial oversight on the sponsor, and in practice that duty lands on you. Delegating work to a CRO or a site does not delegate the accountability for whether it was done.

The escalation. You decide what the sponsor hears and when. A problem you knew about and did not raise becomes your problem the moment it surfaces.

What is not yours

You do not overrule the medical monitor on a safety question. You do not decide eligibility. You do not tell a site how to practice medicine.

Confusing project authority with clinical authority is the fastest way for a project manager to create a protocol deviation. Your authority is over the plan, the vendors and the reporting. Not over clinical judgment.

The test

A useful check on any decision you are about to make: if this goes wrong, does the answer begin with "the project manager decided"? If it does, it should be a decision about sequence, resource or escalation, not about a participant.