Oncology Study Director

1 day ago


Nottingham, Nottingham, United Kingdom Advanced Clinical Full time

Key Responsibilities

  • Participate in the planning, implementing, and managing of clinical trials in compliance with industry regulations and ICH-GCP.
  • Oversight of CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.
  • Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.
  • Collaboration with teams for efficient study start-up, identifying risks and ensuring timelines are met.
  • Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.

Requirements

  • Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and CROs.
  • Strong understanding of GCP, ICH, GDP, and relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.
  • Experience with clinical trial site start-up and initiation.
  • Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.
  • Strong communication skills for coordinating activities with internal teams, sites, and vendors.
  • Proactive in identifying project challenges and proposing corrective actions with minimal supervision.
  • Capable of working independently and delivering high-level presentations.

Salary Information

$120,000 - $150,000 per year.



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