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Senior Director of Clinical Operations

Kelly Services

This is a Full-time position in Westlake, TX posted August 19, 2021.

Kelly Science & Clinical has a new direct hire opportunity for a Senior Director of Clinical Operations with an established Clinical Research company in the Charleston, SC area.

Day-to-Day Responsibilities: Lead and oversee clinical operations staff, CROs, FDA regulatory submissions, and external service providers within established timelines, budgets, and ICH/GCP regulations Develop clinical trial designs with insight from KOLs Manage quality assurance of clinical data Lead development, review, and revision of study documentations, including but not limited to: Clinical Study Reports, Protocols, Operational Study Plans Collaborate with functional leaders to prioritize and drive portfolio excellence Provide innovative and creative solutions, proactively, to move business forward Identify strengths and weaknesses of contributors and strategically present resources to develop the team You would be an excellent fit if you meet the following qualifications: BS/MS/PhD in Life or Health Sciences discipline 4-6 years’ of upper-level Clinical Management experience Demonstrated ability managing CROs, vendors, investigational sites, quality compliance, and clinical trial budgets within established deadlines/budget/resources Clinical Research experience within Biotech/Pharmaceutical Industry Well-versed in GCP and ICH guidelines with active certification highly desired Expert knowledge of drug development process with FDA feedback/negotiation experience Experience with oversight or active participation involved with pre-clinical strategic planning to early/late-stage clinical trials Demonstrated leadership with focus on team development, team building, and/or mentorship

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