Clinical Trial Management Support, Late Phase Metabolic Studies
eliassen groupSioux Falls (SD)
Clinical Trial Management Support, Late Phase Metabolic Studies
Posted 3 days ago
eliassen groupSioux Falls (SD)
SENIORITY
Senior
About the role
Description:
RemoteOur client is seeking a Clinical Trial Manager to support two Phase III global studies in the MASH therapeutic area. The role will provide hands-on operational support for monitoring visit report review, protocol deviation review, Trial Master File oversight, subject tracking, central laboratory coordination, central imaging and procedure vendor coordination, and related study activities. The position will help ensure studies are executed per plans, timelines, procedures, and regulatory requirements while identifying and escalating operational issues. The role reports to the Clinical Program Manager. Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $110.00 to $100.00/hr. w2Responsibilities
Support day-to-day clinical trial execution with Clinical Operations study leads and cross-functional teams. Review monitoring visit reports for quality, completeness, follow-up, and site-level escalation. Review and track protocol deviations, documentation, follow-up, and trend identification. Support subject tracking across screening, enrollment, treatment, and key milestones. Support central laboratory activities, including sample and operational issue tracking and coordination with sites, CROs, and vendors. Support central imaging and procedure vendors, including coordination and tracking of DXA, biopsy, and EGD activities and related issues. Review study data listings and operational reports to identify trends, discrepancies, and follow-up items. Partner with CROs and vendors to track site activities, deliverables, risks, and issues through resolution. Support study documentation, trackers, meetings, cross-functional coordination, and other Clinical Operations activities. Support TMF oversight and inspection readiness, identifying documentation or quality gaps and driving follow-up.
Experience Requirements:
Minimum 4+ years of progressive clinical research experience primarily sponsor side.
Strong Phase III clinical trial operations experience.
Therapeutic area experience in a metabolic or metabolic-adjacent area.
Working knowledge of ICH-GCP and applicable clinical trial regulations.
Organizational skills, attention to detail, and ability to manage multiple priorities.
Written, verbal, and interpersonal communication skills.
Ability to collaborate with cross-functional teams, CROs, sites, and vendors.
Proficiency with Microsoft Word, Excel, and PowerPoint, and familiarity with clinical trial systems and tools.
Education Requirements:
BS/BA in a relevant scientific discipline or an RN qualification (2- or 3-year program).
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