As others have mentioned, I have learned to value effective communication, especially from senior management, where it is more meaningful and importan...

A bid process can be conducted to select the CRO for the clinical trial. The project manager can create and send a request for proposal to multiple CR...

Proper scope change control can mitigate some of the risks of scope creep by identifying changes and taking the steps to get them approved and managed...

Incorporating diverse sites in a clinical trial that are not the major academic hospitals, as you mentioned, would be one of the best ways to involve ...

An individual’s performance, which is also based on their knowledge and current skills, can greatly affect their goals and the paths available to achi...

A communications plan is important in a clinical trial because the project manager will engage with project members and stakeholders at other sites or...

Project management starts in the early stages of a project, but work is also done before project approval is obtained. Before the scope is developed, ...

Procurement processes in the medical device industry are significant due to strict regulatory requirements along with expected quality and safety stan...

Cost estimation tools can help grasp an unknown budget, and potential changes, such as new requirements or design changes, should be incorporated. Mos...

When hiring, whether externally or internally, the PM should consider the project team's size and the need for full-time or part-time availability. Th...

The success of a medical device project depends on stakeholder involvement, among other factors, as their contributions to design, quality, and safety...

Clinical trials, usability testing, and software validation are common methods used in the medical device industry. For example, software validation c...

I have found that the size of the organization or project team has a significant impact on change fatigue. A smaller team struggles to keep up with fr...

Relying too heavily on metrics like EV, PV, and AC can hurt the team when they cannot control the variables that affect them. If the project scope is ...

Incorporating review meetings throughout the project stages is highly recommended for monitoring, and auditors can request a review of the quality of ...