Senior Study Manager - FSP

The Senior Study Manager (SSM) leads and manages the tactical execution of one or more clinical studies of moderate complexity from study startup through database release and inspection readiness to ensure timely delivery of quality study data.

• Provides Operational Study Management for one or more studies of moderate complexity, generally with responsibility for all study management aspects of assigned studies.
• Accountable for the development of realistic detailed study start-up and monitoring plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and Contract Research Organizations (CROs), reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
• Leads study risk planning process in context of site and subject
• Coordinates study/protocol training and Investigator Meetings
• Develops and provides key inputs to Clinical Trial Budget (e.g., per subject costs)
• Accountable for the delivery of the study against approved plans
• Leads inspection readiness activities related to study management and site readiness

Knowledge and Experience:

• Extensive global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs
• Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend
• Understands how to work with vendors to accomplish tasks
• Understands feasibility of protocol implementation

Education:

• For Bachelor’s of Science degree or Nurse – minimum of 5 years relevant experience
• For Master’s of Science degree or Doctor of Philosophy degree – minimum of 3 years relevant experience

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.