ICON plc

Project Manager

ICON plc

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s)
  • Support or oversee execution of select study/ies in compliance with ICH GCP, local regulations and SOPs, on schedule and on budget
  • Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
  • Lead development of Operational Strategy during Early Engagement with Strategic Partners/CROs and prepare for Operational Strategy Review
  • Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
  • Support/review study budget planning and management and accountable for external spend related to study execution
  • Work closely with COM and COPL, Global Program Management, and Finance to ensure budgets, enrollment, and gating are accurate; communicate study status, cost and issues; serve as escalation point for vendors
  • Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and supervision of performance; escalate issues to governance committees when warranted
  • In partnership with data management, review and pressure test database timelines and plans; support data review for database lock and CSR writing and review
  • Collect/review/file study documents in support of the trial master file (TMF) and regulatory filing
  • Oversee study financial reconciliation
  • Ensure studies are inspection ready and prepare for/attend regulatory inspections as needed
  • Site relationship management and oversight of trial audits, including follow up to audit findings and CAPAs
  • Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparation

Requirements

  • Bachelor’s Degree or international equivalent required; Life Sciences preferred.
  • 5+ years’ experience in pharmaceutical industry and/or clinical research organization
  • 3+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA)
  • Experience with early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs
  • Experience in more than one therapeutic area is advantageous
  • Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
  • Awareness of local country requirements
  • Demonstrated successful experience in project/program management and matrix leadership (timeline/budget management, risk identification and management)
  • Works independently and is highly organized
  • Good communication skills
  • Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with leading cross-functional teams, vendor selection and oversight
  • Experience managing recruitment challenges and boosting enrollment
  • Fluent business English (oral and written)