For the simulation the company involved did do their diligence in finding a second backup vendor, however the second vendor had a major cost increase when compared to the first vendor which is where t...

When a vendor evades responsibility for their product there are multiple approaches that a company can take to fix the problem. Depending on the contract signed a company can take the legal approach i...

Outsourcing clinical trials is likely just the most efficient way to conduct a clinical trial for a majority of companies, as the resources necessary for conducting trials could be too expensive to ma...

I think another strategy for improving employee engagement would be to assign responsibilities that an individual can solely be responsible for. When responsibilities are split between multiple people...

There are a lot of challenges unique to clinical trials. This is especially true for multisite clinical trials which not only have to administrate a clinical trial but also coordinate between multiple...

While having a broader specification range seems better at first it does come with multiple problems. As others have said, having a wider specification range than necessary will create problems in the...

I also think it would be best to go with an entirely different supplier, both for the reasons you mentioned as well as others. Quality issues or a disaster at the manufacturing site would result in us...

I would say the three that are the most important are time management, cost management, and risk management. I think these three are all interconnected and effects on one tend to cascade negatively on...

Essentially, all reasons that were given that could affect the schedule variance are just different types of risks. Others have already brough up risk management as a tool to mitigate these risks ther...

The way work is split between multiple PMs can be difficult to figure out and the best way to do it definitely depends on the specific project. The cleanest way to do it in my opinion is to split the ...

I also think that in the context of medical device development projects transformational leadership is the most effective. Transformational leadership allows for not only innovation but also encourage...

Ideally teams should rely on both historical data and expertise when estimating tasks but in practice this may be difficult, especially when historical data is sparse or somehow biased by other factor...

While I do agree that while generally SOPs would be the easiest document to change, it is certainly not always the easiest. It heavily depends on the scope of not only the SOP but also the impact of t...

While it may be beneficial to take a risk to shorten the projects time frame, this decision depends heavily on the magnitude of the benefit, and the size and impact of the risk being incurred. In the ...

I have seen a lot of great responses in this thread especially about the challenged PMs face especially about information. One challenge I think PMs will face when working on projects is simply failin...