GeneDx

Director, Clinical Research Operations

GeneDx

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $229,581 - $275,494 per year

Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Lead the operational strategy and execution of prospective clinical research studies, including site and GeneDx-sponsored efforts.\n
  • Contribute to protocol development, study design, operational feasibility assessments, and other study-specific documentation. This will include collaboration with sites as well as leading the development of materials for GeneDx-sponsored research.\n
  • Oversee study start-up, site management, monitoring, data collection, and close-out activities.\n
  • Ensure internal coordination for study activities, including contracting and laboratory communications.\n
  • Ensure compliance with GCP, HSR, and other applicable regulations.\n
  • Collaborate with cross-functional teams including Medical Affairs, Product, Innovation, and Commercial to align research initiatives with strategic priorities.\n
  • Identify and manage vendors needed to support clinical research activities (e.g., CROs, data management) to ensure quality and timely delivery.\n
  • Develop and manage clinical operations budgets, timelines, and resource plans.\n
  • Support regulatory submissions and interactions with health authorities as needed.\n
  • Develop and maintain SOPs and work guides for clinical research operations.\n
  • Yes\n
  • Build and mentor a high-performing clinical research operations team\n
  • Lead and mentor internal and/or contract clinical research operations staff and clinical data managers\n
  • Oversee resource allocation and workload across team members\n
  • Provide coaching, performance feedback, and career development support\n
  • Foster a collaborative, high-performing team culture\n
  • Good Clinical Practice and Human Subjects Research Certification preferred\n
  • Ability to stand, walk, and sit for extended periods.\n
  • Work is primarily performed in a remote office setting.\n
  • Occasional travel may be required.

Requirements

  • Bachelor's degree in life sciences, public health, or a related field.\n
  • 10+ years of experience in clinical research operations, with at least 5 years in a leadership role.\n
  • Proven experience managing clinical trials in genomics, rare disease, or precision medicine.\n
  • Strong understanding of clinical trial regulations and guidelines.\n
  • Knowledge of clinical research standards and compliance requirements preferred.\n
  • Proficiency in Microsoft Office Suite and project management tools preferred.\n
  • Excellent leadership, communication, and organizational skills.\n
  • Attention to detail and commitment to producing high-quality work.\n
  • Ability to work in a fast-paced, mission-driven environment.