GeneDx is looking to solve diagnostic challenges through sequencing and to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care.
Requirements
- Minimum 3 years of experience in clinical research operations or project management.
- Experience in genomics, diagnostics, or biopharma preferred.
- Strong understanding of clinical research processes, IRB submissions, and study documentation.
- 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 and manage study start-up activities with cross-functional teams and external collaborators for prospective research studies, including identifying all requirements for study readiness
- Coordinate the development of study-specific materials with cross-functional teams, including protocols, informed consent forms, research kits, and documents that support study conduct
- Coordinate execution of research agreements and letters of support for applicable research projects.
- Collaborate with laboratory, bioinformatics, and production teams to ensure awareness and readiness for processing and reporting of study samples
- Develop and maintain detailed study timelines and trackers to ensure on-time delivery of study milestones
- Facilitate regular project meetings, status updates, and issue resolution
- Maintain comprehensive study documentation, including study trackers, meeting notes, and regulatory files
Other
- Bachelor’s degree in life sciences, public health, or a related field.
- Excellent communication, organizational, and stakeholder management skills.
- Attention to detail and commitment to producing high-quality work.
- Ability to manage multiple projects simultaneously.
- Occasional travel may be required.
