Oklahoma City , OK , United States
Ensure clinical study quality and consistency of performance and in conjunction with the Clinical Leader and other Team members is responsible for overall timeline adherence and performance against project plans.
Responsible for peer management and/or support of and coordination with contract research organization personnel (CROs) consultants contractors and other colleagues to ensure that adequate resource volume and quality is maintained on the studies for which the Senior CSM is responsible.
Conduct the assigned activities or manage the CRO in accordance with ICH/GCP/FDA guidelines company policies/SOPs/WPDs and protocol specifications.
Sr. Clinical Study Manager (Sr. CSM) to organize and facilitate the overall planning coordination tracking and general performance of clinical studies that support the Clinical Development Plan. There will be some business travel required as needed.
Requirements: - BS/BA in a health-care or science related field - Minimum of 7 years industry experience including - 2 years as a site CRA and 3 years as a study / project manager for a CRO or pharmaceutical company. - Superior written and verbal communication skills - Excellent peer management skills - Must have a well-defined effective system for multi-tasking.
• EDUCATION: BA/BS healthcare
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