Part 2 of What About Project Management?
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Principle 1: Give the Project Manager the Authority to Make It Work
The classic mistake is to treat project managers as bureaucrats. This is based on the misconception that project management is mostly checking boxes, updating schedules and filing paper. As the design process owners, project managers must have the authority to stop a project when it strays from the design control boundaries. For example, starting a validation study without an approved protocol in order to save time puts a major piece of the project at risk, regardless of the reason. It should go without saying that with the authority comes the obligation to use that power judiciously.
Principle 2: Don’t Give the Project Manager Too Much Authority
Though it might seem counter-intuitive, this really is an important principle. Some companies will hand their flagship project to a senior scientist because of their technical expertise. The danger is that there may be no one paying attention to the design process itself. Most scientific leaders on a project are obligated to make sure the project is scientifically sound, so that's where they spend their time. But who's checking that the design outputs trace to the design inputs?
Giving a project manager the responsibility for both the technical quality and the design process seems like an efficient use of resources, but it carries the risk of key design elements slipping through the cracks. And it also robs the project manager of their most important asset to run a team: departmental neutrality.
Principle 3: Clarify the Roles on a Project
It is very important for senior management to make it clear who is responsible for what on a project. A successful IVD project has both a design process owner, (the project manager), and a technical lead, (the senior scientist). As a project progresses, the person acting as the technical lead may change depending on the design stage, but the responsibility remains the same. Likewise, the project manager owns the design process, and thus is responsible for ensuring that the technical and design control deliverables are in sync.
In my next blog I’ll touch on what it takes to be a successful IVD project manager, and what an organization can do to ensure that success.