Senior Clinical Operations Professional

4 days ago


Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time
About the Role

We are seeking a highly experienced and skilled Senior Clinical Trial Manager to lead our global clinical trial operations. As a key member of our team, you will be responsible for ensuring the successful delivery of our clinical studies.

Key Responsibilities:

  • Oversee all aspects of clinical trial management, including study start-up, maintenance, and close-out.
  • Coordinate and lead cross-functional teams, including CROs and vendors, to deliver high-quality results.
  • Develop and manage clinical trial documents, including protocols, case report forms, and consent documents.
  • Ensure compliance with Good Clinical Practices, national, and international regulatory requirements.
  • Provide oversight and coaching to Clinical Trial Associates allocated to the project.

Requirements:

  • Bachelor's degree in a life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.
  • Minimum 8+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizations.
  • Prior phase II and III experience required.
  • Solid understanding of the drug development process, ICH guidelines/GCP, and each step within the clinical trial process.
  • Experience with budget forecasting and management.
  • Excellent interpersonal and decision-making skills.
  • Demonstrated ability to lead teams and work in a fast-paced environment.

Estimated Salary Range: $165,000 - $195,000 annually.

About Us

Summit Therapeutics Sub, Inc. is a leading biopharmaceutical company dedicated to developing innovative treatments for patients with rare and orphan diseases.



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