Clinical Trial Lead

ICON Clinical Research, LP

Multiple Locations
Ich/gcp guidelines and regulatory requirements
Cross-functional trial team oversight
Investigator and site monitor training
Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements

Job Summary

  • Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
  • Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies.
  • Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials.

Matching Summary

Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Skills & Requirements

Must-have

  • ICH/GCP guidelines and regulatory requirements
  • Cross-functional trial team oversight
  • Investigator and site monitor training
  • Vendor capability assessment
  • Feasibility assessment and site selection
  • Phase I oncology experience
  • Global experience

Nice-to-have

  • Strategic problem solving
  • Patient-focused strategies implementation
  • Process improvement initiatives
  • KOL interactions management

Key Requirements

  • BA/BS degree with at least 5 years clinical trial experience
  • Advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
  • Strong knowledge of ICH/GCP guidelines
  • Strong knowledge of protocol and clinical drug development processes
  • Proven project management skills
  • Trial leadership ability
  • Experience working with China preferred

Work Rights

Not specified

Tailored Resume

Cover Letter