Associate Director
Clinical Operations
Posted on 2/6/2024
Arcellx
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
CategoriesNew
Operations & Logistics
Requirements
  • BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent)
  • 8+ years of clinical operations experience, including some experience with early phase research design
  • Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements
  • Exceptional project management skills, organizational and problem-solving skills
  • Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions
Responsibilities
  • Oversees scope, quality, timelines, and budget for early-stage autoimmune clinical trial
  • Lead site and study management activities, including development of critical study documents
  • Provide study-specific training and leadership to clinical research staff
  • Effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics
  • Anticipate obstacles or complex issues at the site, vendor, and study levels, and implements solutions
  • Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation
  • Develop and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes
  • Review the quality and integrity of the clinical data through review of electronic CRF data; work with CRO/sites to resolve data queries
Desired Qualifications
  • Eager to learn with a collaborative, team-oriented mindset