Like any other project, the Project Manager is fully involved in pre-clinical studies. PMs are involved in the preparation of the business case and need for the study, developing the schedule, budget, and coordinating the team through each stage (planning, executing, controlling, and closing). As a team, each subject matter expert (SME) will contribute in the development and approval of the study protocol, identifying the tests that will need to be done to receive the desired results for a specific claim, and will also conduct thorough literature research in what has been done in the past. The SMEs will also review any SOPs that are currently in place in the company and the PM will ensure that the SOPs are updated in respect to regulations and the intended research study. Important people that need to be contacted are the stakeholders (i.e. animals, technologists, scientists, veterinarians, facility managers and staff, etc.), funding bodies (i.e. NIH), ethical review boards, national committees, and regulatory authorities (pre-approval and guidance of the study). The PM with their project team will define strategies and identify alternative solutions when necessary. The PMs will manage the selection of full time employee (FTE) resources and outsourcing to contract research organizations (CROs), coordinate the study activities ensuring they are completed on time, be a part of reviewing validation documentation and results, and review the materials that will be submitted to obtain a regulatory claim or approval.