Director Clinical Trial Management

Found in: beBee jobs US - 2 weeks ago


New York, New York, United States i-Pharm Consulting Full time

Summary of Responsibilities

Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulationsServe as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic area, and indicationProvide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is providedReview and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicableDevelop operational project plansManage risk assessment and executionManage study vendors where applicableManage site quality and monitoring deliverablesEducation, Qualifications, and ExperienceBachelor's degree in a health-related field; Advanced degree in a health-related field preferredExperience in Phases 1-4; Phases 2-3 preferred5+ years as a project/clinical trial manager within a CROManagement of overall project timelineBid defense experienceStrong leadership skills
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