Clinical Operations Director

1 day ago


Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

Job Summary

The Director of Clinical Operations is responsible for leading the development of a Clinical Operations Team in the United States. This role will work closely with the Function Head to plan and assign resources across studies.

Key Responsibilities

  • Team Leadership
    • Lead a team of Project Managers, Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs) in the development and execution of clinical trials.
    • Mentor, motivate, and train team members to ensure they have the necessary skills and knowledge to perform their roles effectively.
  • Operational Management
    • Oversee and manage all operational aspects of phase I-IV US-based or global clinical trials, including study start-up, site management, and vendor oversight.
    • Act as the primary point of contact for internal and external stakeholders for planning, conduct, and reporting of assigned trials.
  • Vendor Management
    • Participate in the vendor selection process, including proposal development, bid-defense, and contract review.
    • Oversee vendor performance, including timelines and deliverables.
  • Financial Management
    • Prepare and review budgets for studies managed in-house and review professional fees and pass-through costs for CROs, SMOs, Investigators, and vendors.
    • Manage and track study budgets, project milestones, and timelines throughout the life of the study.
  • Quality Assurance
    • Develop and implement quality control plans to ensure clinical studies are in compliance with ICH-GCP, SOPs, and applicable regulations.
    • Perform co-monitoring and vendor oversight visits to ensure quality of trial conduct.
  • Communication and Collaboration
    • Provide status updates to stakeholders as required.
    • Collaborate with cross-functional groups to ensure required deliverables are met.

Secondary Responsibilities

  • Participate in audit and assessment activities.
  • Support the development of clinical development strategies.
  • Contribute to departmental activities, including training and initiatives.

Requirements

Education and Qualification

Bachelor of Science in a life sciences discipline or higher qualification.

Experience

10+ years of clinical trial experience.



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