Forum

yg383
@yg383
Eminent Member
Joined: Jan 24, 2025
Last seen: May 4, 2025
Topics: 0 / Replies: 36
Reply
RE: Motivation factors

Career satisfaction in clinical trial project management, or really any field, isn’t just about checking tasks off a list or hitting deliverables. Ove...

1 week ago
Reply
RE: Role of Communication Plans in Clinical Trial Execution

Totally agree that communication plans don’t always get the attention they deserve, even though they’re such a big part of what keeps a clinical trial...

1 week ago
Reply
RE: Balancing Cost, Time, and Quality in Clinical Trials

Balancing cost, time, and quality in clinical trials is definitely a tough equation, especially since quality really isn’t something that can be compr...

1 week ago
Reply
RE: Protocol Deviations vs. Violations in Clinical Trials

Reading through this discussion made me think about how protocols work in different settings. I'm not 100% sure in real life how clinical trial protoc...

2 weeks ago
Reply
RE: Dealing with Low Performers in Research Teams Without Losing Morale

Reading through everyone's replies, I appreciate how much emphasis is being put on understanding the root causes of underperformance. From my own expe...

2 weeks ago
Reply
RE: Keeping Clinical Research Teams Motivated During Long Timelines

Something that ties into it all is how mental health and burnout can creep in during long projects, especially when people feel like their concerns or...

2 weeks ago
Reply
RE: Scope Management Optimization Strategies

Scope management can get complicated fast, especially when project goals shift or new requests come in from leadership. One approach that helps handle...

3 weeks ago
Reply
RE: Human Resource Management

Many of the tools mentioned, like FMEA, RCA, and scenario-based simulations, are essential for safety-critical projects, especially regarding systems-...

3 weeks ago
Reply
RE: Navigating Compressed Schedules

The risks and trade-offs of duration compression in medical device projects are complex. Both crashing and fast tracking can offer time savings, but t...

3 weeks ago
Reply
RE: Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical

I really appreciate how this discussion emphasizes the importance of long-term responsibility in medical device management. One thing that stands out ...

1 month ago
Reply
RE: Challenges of Using SV and CV in Medical Device Project Management

There’s a lot of great insight here, especially around how SV and CV can be distorted in the complex and evolving landscape of medical device developm...

1 month ago
Reply
RE: Making Design Reviews Work in Medical Devices

These are all great insights, and I agree that preparation sets the stage for a smooth and productive design review. One thing that I think also helps...

1 month ago
Reply
RE: Change in Scope Due to Customer Requests

In biomedical device development, I feel like managing scope changes after execution starts can be especially tricky, not just because of timelines an...

1 month ago
Reply
RE: Implementing Change Without Disrupting Production

This seems like it would be classified as a major change from a project management and regulatory perspective, especially since it affects a functiona...

1 month ago
Reply
RE: Managing Change Fatigue

One area I think could be further explored in managing change fatigue is how we track and reflect on it beyond anecdotal signs. While we often “sense”...

1 month ago
Page 1 / 3