Based off the limited information you have on the project you chose – you have several known and unknown risks.

1. There are 2 discussion problems that must be addressed in order to get the possible full credit for this assignment (100 points). 2. Please review the Module 7 materials for this course prior to completing the assignment. 3. As a student you are required to review the Business and Globalization in Clinical Research Presentation.
Discussion Problem One (75 points): Please review the two project management scenarios and answer the questions below.
(Scenario I):
As the clinical trial project manager you are managing a Phase III influenza trial involving 250 investigative sites (North America, Europe, and Latin America) and 2500 patients. It is crucial that the company finish enrollment in the 12 month period and being able to track influenza outbreak while managing study startup will be a critical part of the project. You have had an initial meeting with the key stakeholders at the pharma company and the key stakeholders have already developed a design for the clinical trial and are finishing the draft protocol.
(Scenario II)
As the clinical trial project manager you are managing a Phase I solid tumor (oncology) trial involving 4 investigative sites (3 US, 1 France) and 30 patients. It is crucial that the company determine the maximum tolerated dose (MTD) of the study drug and communication amongst the investigate sites and the sponsor will be crucial to the success of the trial. You had an initial meeting with key stakeholders and have already developed a design for the clinical trial and are finishing the draft protocol.
1. Which project would you choose to manage and why did you choose this specific project? (5 pts)
a. Please use the scenario you selected to answer the remaining questions
In this module you attended the business and globalization of clinical research lecture and we discussed how to approach these types of global projects. Describe how you would manage the following: (40 pts)
a. Disease indication?
b. Patient and Site Selection?
c. Timelines?
d. Communication Plan?
3. In this module you learned the key principles of being a project manager. Please describe 2 responsibilities of a project manager. (10 pts)
4. Three are multiple tools and techniques you can use to manage the project. Describe at least 5 tools you would use as a project manager? (20 pts)Format your assignment as follows:
Include your name at the top of the page
Number all pages
Remember to review and revise your paper several times to ensure that your final paper is of high quality and there are no grammatical errors. Please use professional language. Do not use slang or colloquialisms.
Submit your paper as an MS Word documentDiscussion Problem Two (25 points) As stated in Module 7, timeline tracking is crucial for a project manager.
A Gantt chart is commonly used to communicate a project plan and is usually produced after a detailed and well-planed list of tasks has been created.
Gantt charts can be easily developed by using MS Project or Excel (project training links were included in Module 7 and several resources can be found on line, including you tube).

The objective of this exercise to develop a Gantt chart
Please pick a topic of your choice (theres no right or wrong answer)
o Eg: Final Protocol
o Eg: First Patient In
o Eg: Investigational Product Shipped
o Eg: Investigators Meeting
o Eg: Monitoring Visit Report
Identify the tasks needed to complete the project (minimum of 10 tasks)
Identify the time required for each task
Identify the sequence
o Which tasks must be finished before a following task can begin?
o Which tasks can happen simultaneously?
o Which tasks must be completed before each milestone?

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