One way to look at the decision is through the balance between control and consistency. A company running a clinical trial in-house keeps direct oversight of how the study is executed, how data is handled, and how quickly adjustments can…   Read more»

One point worth taking seriously from this discussion is that project management thinking is not something that only applies to whoever holds the official title. People in purely technical roles carry that perspective into their work too, and it changes…   Read more»

A project manager works with sponsors by serving as the link between what the sponsor is asking for and what the team can realistically put out. That means picking up broad goals and converting them into actual tasks, timelines, and…   Read more»

The response brings up a fair point about whether partnering with a CRO actually takes risk off the table, and the honest answer is that it depends far less on the CRO’s reputation and far more on how well that…   Read more»

That situation illustrates how one weak point in a clinical trial can put pressure on the whole operation, not just the schedule but the people carrying it. When the response leans on communication and support, that is reasonable, but it…   Read more»

A project manager in the medical field is not just overseeing timelines and deliverables. The nature of the work ties directly into how safe patients are, how well products hold up, and whether the team around them understands why any…   Read more»

The concern about cost versus meaningful team development makes sense, but those two ideas do not have to work against each other. Team development can be evaluated the same way other parts of a project are evaluated by looking at…   Read more»

The post makes a good point about the WBS being the backbone of scope management. However, how it helps with real project decisions is what keeps it useful without making it too complicated. One way to approach this is by…   Read more»

In the case of a project manager‚ this would mean looking at the schedule first from the activities themselves and the nature of the critical path․ In fact‚ this process can be devoid of a decision on whether or not…   Read more»

Coordinating the ten knowledge areas requires treating the project as one connected system rather than separate parts. One effective way to approach this is by maintaining a unified baseline that links scope, schedule, and cost, then using that baseline to…   Read more»

The question of hiring from within the company or from outside is not about choosing one option as universally better, but about matching the hiring decision to the needs of the project. A project manager should first look at what…   Read more»

Changing or omitting activities also affects what the project can deliver․ The sequence essentially defines what will be done‚ what will be tested‚ what will be accepted in the end product‚ and what will not be acceptable․ Furthermore‚ changes to…   Read more»

The post raises a strong point about how change control can either stabilize a project or slow it down depending on how it is applied. It can be added that the purpose of a change control system is not only…   Read more»

The post raises a strong point about how earned value management can be used to monitor project success, but it’s important to remember that these metrics are just one aspect of the monitoring and control process. In practice, EV, PV,…   Read more»

Depending on how the process is organized and presented, a balanced approach to change control can lessen fatigue without compromising compliance. Fatigue tends to build when changes interrupt work too often and without clear prioritization. One effective approach is to…   Read more»

One perspective is that the issue is not choosing between meetings and emails, but designing communication so it supports the work being performed during project execution. During the executing stage of a project, teams are actively completing work packages, coordinating…   Read more»

One way to deal with this kind of situation is through project execution and project control․ During project execution, the work contained in the work breakdown structure is performed․ Progress is monitored, and if performance deviates from the project plan,…   Read more»

Another problem with scope verification during a medical device development project is the slow drift between technology and scope in the execution phase, where too much time is spent on performing experiments, building prototypes and testing items as defined in…   Read more»

This new definition of a stakeholder is reasonable, particularly in the realm of medical device development, where the scope of the project’s influence far exceeds the boundaries of those who have provided the funding. It becomes clear that a stakeholder…   Read more»

The post highlights an important issue in medical device development. Capturing lessons learned only has value if those insights actively shape future decisions. In regulated environments, documentation drives action. For that reason, the most effective format may be one that…   Read more»