GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

Summary

The Associate Director, Clinical Research Operations will play a key role in the execution of prospective and retrospective research studies and external collaborations. This position is responsible for managing study start-up activities, coordinating with internal and external stakeholders, and supporting research services projects. The ideal candidate is detail-oriented, collaborative, and experienced in clinical research project management.

Job 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
Partner with commercial and biopharma teams to support the review, start-up, and execution of research services projects
Manage central IRB submissions and renewals for GeneDx-sponsored research projects
Ensure research activities comply with IRB requirements, HIPAA, and internal SOPs

Education, Experience, and Skills

Bachelor’s degree in life sciences, public health, or a related field.
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.
Excellent communication, organizational, and stakeholder management skills.
Attention to detail and commitment to producing high-quality work.
Ability to manage multiple projects simultaneously.

Certificates, Licenses, Registrations

Good Clinical Practice and Human Subjects Research Certification preferred

Physical Demands

Ability to stand, walk, and sit for extended periods.

Work Environment

Work is primarily performed in a remote office setting.
Occasional travel may be required.

#LI-REMOTE

Pay Transparency, Budgeted Range$153,053—$191,317 USD

Science - Minded, Patient - Focused.

At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.

Experts in what matters most.

With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.

SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.

From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:

TECHNICAL EXPERTISE

High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.

CLINICAL EXPERTISE

Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.

Learn more About Us here.

Our Culture

At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job—you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:  

Be bold in our vision & brave in our execution. 
Communicate directly, with empathy. 
Do what we say we're going to do.  
Be adaptable to change.  
Operate with a bias for action.

Benefits include:

Paid Time Off (PTO)
Health, Dental, Vision and Life insurance
401k Retirement Savings Plan
Employee Discounts
Voluntary benefits

GeneDx is an Equal Opportunity Employer.

All privacy policy information can be found here.