I agree that it does require social skills and this classes forces you to experience real life situations. For example with the simulations you are assigned a group, you don't get to select the people...

Just to add to the conversation of determining Significant vs Non significant risk medical device studies, the FDA has a guidance document. The guidance document is intended to provide information an...

I agree that MDD and AMDD have been integral in providing me the necessary platform not only for my other classes, but for my career. I currently work on the business end, but I am new to the medical ...

I agree these simulations really allowed for us to think creatively on how to solve problems using methods we learned in lecture. I really enjoyed learning about planning and how important it is that ...

I think I would like to a Clinical Project Manager as @Devarshi mentions as a project manager you are able to interact with all departments through the different phases from initiation to closure. It ...

Going over the PM processes for clinical trial management in lecture, I started thinking about technology used to optimize clinical trials. From enrollment and patient consents, to monitoring, I know...

My goal is helping others. Helping others makes me feel good, and I work at Sloan Kettering Cancer Center. When you go to the main hospital and see the patients' faces, you get motivated that you are ...

In my experience at Sloan Kettering we have encountered as many have mentioned advantages and disadvantages to using CROs. At Sloan we have an efficient and accomplished clinical department which incl...

I agree with many have already stated-that you want to make sure you maintain the quality and integrity of the study and not focus just on the cost. However working at a hospital, I know that budget i...

Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, and GMPs 21 CFR 820 since...

To add to this, clear definitions, and attachments with supporting material for timeline, deliverables, pricing, and business and legal contact information. Thinking about the important articles to in...

We learned in lecture this week that Analogous Cost Estimating is quick, less accurate, less costly, tasks don’t need to be identified, gives PM idea of management expectations, and overall project co...

Communication is key- I believe the PM is responsible for clear communications between the project team members, departments, and key stakeholders. The PM also needs to have business acumen to determi...

I agree with @merzbrashed that GMPs ensure that production of a good quality product and create credibility for a company. At first glance, it might seem burdensome and costly for manufacturers to fol...

As we learned in lecture, management creates the culture of the company and is responsible for establishing the environment and continuous improvement is a must. Does your company's management underst...