Clinical Trial Operations Lead

1 settimana fa


Roma, Lazio, Italia Vertex Pharmaceuticals A tempo pieno
Job Overview

The Clinical Trial Operations Lead will be responsible for leading global or regional-based activities on complex clinical trials across various study phases, ensuring timely completion of deliverables and maintaining quality throughout the trial lifecycle.

Key Responsibilities:
  • Accountable for executing assigned clinical trials at the global or regional level, adhering to agreed-upon operational strategies.
  • Coordinates internal and external clinical trial management activities for assigned study team members involved in trial planning, start-up, conduct, and closure.
  • Collaborates with the Clinical Operations Program Lead or global Clinical Operations Study Lead in developing operational strategies and initial timelines.
  • Create detailed study timelines with minimal support and monitors progress with cross-functional study team input.
Requirements:
  1. Bachelor's degree in a life sciences discipline or relevant field.
  2. Extensive work experience in the biopharmaceutical industry or equivalent combination of education and experience.
  3. Strong track record in clinical trial management, demonstrating proficiency in project management skills, cross-functional study operations, and vendor management.
  4. Demonstrated understanding of GCP, CFR, and ICH guidelines.
  5. Excellent interpersonal and communication skills to effectively interface with key medical personnel at investigational sites.
  6. Ability to problem-solve within a cross-functional team and manage issue identification and resolution.
Benefits:
  • Competitive salary: $120,000 - $180,000 per annum
  • Opportunity to work on complex clinical trials
  • Professional growth and development opportunities
  • Flexible working arrangements, including remote work options


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