Per definition of PMI (Project Management Institute), project managers across different industries are assigned by the performing organization to achieve the project objectives. This is a challenging, high-profile role with significant responsibility and shifting priorities. It requires flexibility, good judgment, strong leadership and negotiating skills, and a solid knowledge of project management practices. A project manager must be able to understand project detail but manage from the overall project perspective. As the person responsible for the success of the project, a project manager is in charge of all aspects of the project including, but not limited to:
Inspection Readiness (IR) is a proactive process. It is a process of ‘getting ready’ for an inspection by a regulatory authority (such as FDA), which is conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial. 
Effective communication builds trust, is critical to the success of any project and represents one of project management’s most important responsibilities. Excellent communication within the project team and between the project manager, team members, and all external stakeholders is essential and is correlated with a high team performance. 
Per definition of 
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