GeneDx is looking to solve diagnostic challenges through sequencing and improve patient care by leading the strategic and operational execution of clinical programs, ensuring regulatory compliance, and driving operational excellence in research and development.
Requirements
- Proven experience managing clinical trials in genomics, rare disease, or precision medicine.
- Strong understanding of clinical trial regulations and guidelines.
- Knowledge of clinical research standards and compliance requirements preferred.
- Proficiency in Microsoft Office Suite and project management tools preferred.
- Good Clinical Practice and Human Subjects Research Certification preferred
Responsibilities
- Lead the operational strategy and execution of prospective clinical research studies, including site and GeneDx-sponsored efforts.
- Contribute to protocol development, study design, operational feasibility assessments, and other study-specific documentation.
- Oversee study start-up, site management, monitoring, data collection, and close-out activities.
- Ensure internal coordination for study activities, including contracting and laboratory communications.
- Ensure compliance with GCP, HSR, and other applicable regulations.
- Identify and manage vendors needed to support clinical research activities (e.g., CROs, data management) to ensure quality and timely delivery.
- Develop and maintain SOPs and work guides for clinical research operations.
Other
- 10+ years of experience in clinical research operations, with at least 5 years in a leadership role.
- Excellent leadership, communication, and organizational skills.
- Attention to detail and commitment to producing high-quality work.
- Ability to work in a fast-paced, mission-driven environment.
- Build and mentor a high-performing clinical research operations team
