Clinical Operations Director

Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: September 30, 2024

Job Description:

Director, Clinical OperationsAbout the RoleWe are seeking an experienced Director, Clinical Operations to lead our Clinical Operations Team in the United States. As a key member of our team, you will be responsible for the development and implementation of clinical trial strategies, as well as the management of operational aspects of phase I-IV US-based or global clinical trials.Key Responsibilities

• Lead the Clinical Operations Team in the United States, providing guidance and oversight to Project Managers, Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs).
• Oversee and manage all operational aspects of clinical trials, including study start-up, site identification, feasibility, site selection, contract negotiation, and clinical study agreement finalization.
• Act as the primary point of contact for internal and external stakeholders, including vendors, CROs, and investigators.
• Develop and implement quality control plans to ensure compliance with ICH-GCP, SOPs, and applicable regulations.
• Manage and track study budgets, project milestones, and timelines throughout the life of the study.
• Prepare and review study plans, protocols, and other study-related documents.
• Coordinate with cross-functional groups to ensure timely completion of study deliverables.
• Perform co-monitoring and vendor oversight visits to ensure quality of trial conduct.
• Provide status updates to stakeholders as required.Requirements
  • Bachelor of Science in a life sciences discipline or higher qualification.
  • 10+ years of clinical trial experience, with a minimum of 5 years in a leadership role.
  • Proven track record of successfully leading clinical operations teams and managing complex clinical trials.
  • Excellent communication and leadership skills, with the ability to work effectively with cross-functional teams.
  • Strong analytical and problem-solving skills, with the ability to think critically and make sound decisions.What We OfferAs a Director, Clinical Operations at Sun Pharmaceutical Industries, Inc., you will have the opportunity to work on complex clinical trials, lead a talented team of professionals, and contribute to the development of new treatments for patients worldwide.

Keywords: Sun Pharmaceutical Industries, Inc., Trenton , Clinical Operations Director, Executive , Princeton, New Jersey