GeneDx

Associate Director, Clinical Research Operations

GeneDx

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $153,053 - $191,317 per year

Job Level

Senior

About the role

  • 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\n
  • Coordinate the development of study-specific materials with cross-functional teams, including protocols, informed consent forms, research kits, and documents that support study conduct\n
  • Coordinate execution of research agreements and letters of support for applicable research projects.\n
  • Collaborate with laboratory, bioinformatics, and production teams to ensure awareness and readiness for processing and reporting of study samples\n
  • Develop and maintain detailed study timelines and trackers to ensure on-time delivery of study milestones\n
  • Facilitate regular project meetings, status updates, and issue resolution\n
  • Maintain comprehensive study documentation, including study trackers, meeting notes, and regulatory files\n
  • Partner with commercial and biopharma teams to support the review, start-up, and execution of research services projects\n
  • Manage central IRB submissions and renewals for GeneDx-sponsored research projects\n
  • Ensure research activities comply with IRB requirements, HIPAA, and internal SOPs\n
  • Bachelor’s degree in life sciences, public health, or a related field.\n
  • Minimum 3 years of experience in clinical research operations or project management. Experience in genomics, diagnostics, or biopharma preferred.\n
  • Strong understanding of clinical research processes, IRB submissions, and study documentation.\n
  • Knowledge of clinical research standards and compliance requirements preferred.\n
  • Proficiency in Microsoft Office Suite and project management tools preferred.\n
  • Excellent communication, organizational, and stakeholder management skills.\n
  • Attention to detail and commitment to producing high-quality work.\n
  • Ability to manage multiple projects simultaneously.\n
  • Good Clinical Practice and Human Subjects Research Certification preferred

Requirements

  • Bachelor's degree in life sciences, public health, or a related field.\n
  • Minimum 3 years of experience in clinical research operations or project management. Experience in genomics, diagnostics, or biopharma preferred.\n
  • Strong understanding of clinical research processes, IRB submissions, and study documentation.\n
  • Knowledge of clinical research standards and compliance requirements preferred.\n
  • Proficiency in Microsoft Office Suite and project management tools preferred.\n
  • Excellent communication, organizational, and stakeholder management skills.\n
  • Attention to detail and commitment to producing high-quality work.\n
  • Ability to manage multiple projects simultaneously.\n
  • Good Clinical Practice and Human Subjects Research Certification preferred