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mh746 replied to the topic "What’s Your Motivator?" – 1 week, 3 days ago
For me, one of the strongest motivators has always been career advancement. I’m someone who thrives when I can see a clear path ahead—whether it’s gaining a new skill, taking on more responsibility, or earning a new opportunity. Knowing that… Read more»
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mh746 posted a new topic "The Manager’s Role in Sustaining Team Engagement During Trials" – 1 week, 5 days ago
Clinical trials are long, demanding projects, and keeping teams motivated and engaged over time is a major leadership challenge. Managers aren’t just responsible for timelines and deliverables—they also set the tone for team energy and focus. If engagement drops, mistakes… Read more»
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mh746 replied to the topic "Contingency Planning" – 1 week, 5 days ago
In high-stakes projects like medical devices, I think one of the best ways to convince management about investing in contingency planning is to speak their language: risk vs. cost analysis. Instead of just suggesting a second vendor as “extra caution,”… Read more»
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mh746 posted a new topic "Keeping Clinical Research Teams Motivated During Long Timelines" – 2 weeks, 4 days ago
One of the biggest challenges in clinical research is maintaining team motivation throughout the long and often repetitive phases of a trial. Clinical studies can stretch over several months or even years, and during that time, momentum can easily be… Read more»
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mh746 posted a new topic "Dealing with Low Performers in Research Teams Without Losing Morale" – 2 weeks, 4 days ago
In clinical research projects, one underperforming team member can affect not just productivity, but also team morale. This is especially critical when the timeline is tight and regulatory standards are high. A real-world example of this occurred during the development… Read more»
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mh746 replied to the topic "Creating Realistic Schedules in Clinical Trials" – 2 weeks, 4 days ago
You bring up a great point, clinical trials are uniquely unpredictable compared to other types of projects. In addition to IRB approval delays and patient health fluctuations, other common challenges include slow patient enrollment, site compliance issues, and protocol deviations…. Read more»
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mh746 replied to the topic "Maximizing Quality Management" – 3 weeks, 1 day ago
I think it’s true that focusing too much on just meeting regulatory requirements can limit the full potential of quality management. Regulations are important for safety and consistency, but they’re only the starting point. A good example is the Johnson… Read more»
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mh746 posted a new topic "Allergan's BIOCELL Breast Implant Recall: A Case Study in Quality and Risk Management" – 3 weeks, 4 days ago
I recently came across the 2019 recall of Allergan’s BIOCELL textured breast implants. The FDA requested this recall after data linked these implants to a rare cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Out of 573 reported cases… Read more»
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mh746 replied to the topic "Critical Path, PERT, and Managing Time Under Uncertainty" – 3 weeks, 4 days ago
Effectively communicating the trade-offs between time compression methods like crashing and fast tracking, and the risks they pose to cost and qualit, requires project managers to be both strategic and practical in their communication approach. One clear example comes from… Read more»
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mh746 replied to the topic "Procurement Management and environmental/social policies" – 3 weeks, 4 days ago
Using procurement as leverage to encourage suppliers to adopt environmental and social policies can be ethical and effective when handled responsibly. The key is balance, ensuring transparency, fairness, and providing adequate support so suppliers can realistically achieve these expectations.For example,… Read more»
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mh746 replied to the topic "Tools and techniques in project management" – 3 weeks, 4 days ago
Project management software significantly simplifies and enhances the accuracy of project planning and execution. While these tools do not fully automate setting dates and budgets without human oversight, they substantially ease this process by handling calculations, resource allocation, and forecasting.For… Read more»
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mh746 posted a new topic "Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical" – 1 month ago
In 2015, Medtronic encountered major regulatory trouble over its SynchroMed II Implantable Infusion Pump. After nearly a decade of inspection findings, the FDA concluded that Medtronic repeatedly failed to address manufacturing violations, including inadequate procedures for identifying and correcting quality… Read more»
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mh746 posted a new topic "Challenges of Using SV and CV in Medical Device Project Management" – 1 month ago
When managing medical device projects, understanding where our project stands in terms of schedule and budget is important. This is where Schedule Variance (SV) and Cost Variance (CV) come into play, both of which are key components of Earned Value… Read more»
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mh746 posted a new topic "The Impact of Earned Value Management (EVM) on Project Budgeting" – 1 month ago
Hello everyone, in the complex world of project management, staying on budget while effectively tracking performance is paramount. Earned Value Management (EVM) is a powerful tool that addresses these challenges by integrating measurements of project scope, schedule, and cost into… Read more»
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mh746 replied to the topic "What’s the Most Effective Form of Communication in Medical Device Projects?" – 1 month ago
In medical device projects, where precision and clarity are paramount, combining formal and informal communication methods often proves most effective. A strategic mix of these methods can address the fast-paced and intricate demands of such projects. For instance, structured weekly… Read more»
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mh746 replied to the topic "How Many Project Update Meetings Are Necessary to Keep them Productive" – 1 month, 2 weeks ago
To determine the ideal number of project update meetings, it’s important to consider the project’s scope and the team’s communication needs. A practical approach might be to use a flexible scheduling system that adjusts based on the project’s phase. For… Read more»
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mh746 replied to the topic "Change in Scope Due to Customer Requests" – 1 month, 2 weeks ago
When a customer requests changes after project execution has begun, a proactive and collaborative approach can effectively manage these changes while minimizing disruption. Firstly, I would suggest implementing a rapid prototyping session with the customer to explore the requested changes… Read more»
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mh746 replied to the topic "Role of Monitoring & Controlling in Project Success" – 1 month, 2 weeks ago
Monitoring and controlling are important in running a project towards success, making sure it adheres to planned objectives related to scope, timeline, budget, and quality. While tools like earned value management (EVM) provide quantitative data on project health, focusing solely… Read more»
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mh746 replied to the topic "Importance of Lessons Learned in the Project Closing Phase" – 1 month, 2 weeks ago
At the end of a project, having a “reflection session” can be very useful. In this session, the team can sit together in a relaxed setting and share what they think went well and what didn’t. For instance, if a… Read more»
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mh746 replied to the topic "Optimizing Information Distribution" – 2 months ago
Effective information distribution is a critical component of project management, particularly in how it influences productivity and clarity within a team. Striking the right balance between communication and actual task execution can significantly impact a project’s success. In practice, too… Read more»
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