Clinical Research Project management is a carefully planned and organized effort to accomplish a specific (and usually) one-time objective, for example, clinical trials Management. Project management includes developing a project plan, which includes defining and confirming the project goals and objectives, identifying tasks and how goals will be achieved, quantifying the resources needed, and determining budgets and timelines for completion. It also includes managing the implementation of the project plan, along with operating regular 'controls' to ensure that there is accurate and objective information on 'performance' relative to the plan, and the mechanisms to implement recovery actions where necessary. Projects usually follow major phases or stages including feasibility, definition, project planning, implementation, evaluation and support/maintenance.
Clinical Research General areas of responsibility include: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between CRO project team, Sponsor, contract and financial management.
- Clinical Research cycle
- Clinical Data Management Life cycle
- Project Management life cycle
- Project Management tools
- Case studies.
Duration: 11 Months.
Bachelor's, Masters, or a Ph.D. in a Science or Allied Health Field; OR Healthcare Professional Medical Technologist, B.sc, M.sc life sciences.Pharmacy, Biotech, Computer.MBA Biotech

Life Science Leader, October 2009
Written by: Dan Schell
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