Clinical Data Management Jobs in USA with Visa Sponsorship
Clinical Data Management roles qualify for H-1B visa and O-1 visa sponsorship as specialty occupations requiring a bachelor's degree or higher in life sciences, statistics, or a related field. Employers in biotech, pharma, and CROs regularly sponsor candidates with CDM experience. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsCompany Overview:
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.
Position Overview
Prime Medicine is seeking an experienced Associate Director of Clinical Data Management to lead clinical data strategy and execution across gene editing programs from first-in-human studies through regulatory submission. This role will oversee all internal and external data management activities supporting INDs, CTAs, BLAs, and global regulatory filings. The ideal candidate has experience in rare disease clinical trials, vendor oversight, and complex biologic or gene therapy programs, and is comfortable operating in a fast-paced environment. This individual will ensure clinical data integrity, regulatory readiness, and high-quality execution across the development portfolio. This role reports to the Senior Director, Clinical Operations.
Key Responsibilities
Clinical Data Leadership:
- Lead all clinical data management activities across multiple programs from IND through BLA submission.
- Develop and execute data management strategies aligned with regulatory requirements both in the US/ex-US.
- Oversee CRF design, database build, edit checks, data review, coding, reconciliation, and database lock.
- Ensure implementation of CDISC standards (SDTM/ADaM) to support submission readiness.
- Support inspection readiness and maintain audit-ready documentation.
Vendor Oversight & Governance:
- Lead selection, oversight, and performance management of CRO and data management vendors.
- Manage vendor budgets, timelines, KPIs, and quality metrics.
- Oversee external data transfers and reconciliation processes (e.g., SAE, lab, PK and PD).
- Ensure change control, database archiving, and data governance processes are compliant and well documented.
Gene Therapy & Rare Disease Expertise:
- Oversee integration of complex data streams including:
- Genomic and sequencing data
- Biomarker and translational endpoints
- Immunogenicity and PK/PD
- Long-term follow-up safety data
- Support dose-escalation studies with rapid data review cycles and SRC/DMC readiness.
- Tailor data processes to rare disease trial realities (small populations, adaptive designs, multi-cohort studies).
Systems & Infrastructure:
- Contribute to scalable data infrastructure and identification of key efficiencies between programs.
- Support implementation and optimization of EDC, ePRO, IRT, and data visualization systems.
- Ensure integration between clinical data, laboratory systems, and sample tracking systems.
Cross-Functional Collaboration:
- Partner with Clinical Development, Clinical Operations, Regulatory, Quality, and Translational Sciences.
- Serve as subject matter expert for data standards, governance, and process improvement initiatives.
- Contribute to development and improvement of internal SOPs and workflows.
Qualifications
- Bachelor’s degree in life sciences, statistics, informatics, or related field (advanced degree preferred).
- 8+ years of progressive clinical data management experience, including leadership responsibility.
- Experience supporting IND submissions and major regulatory filings (BLA/NDA/MAA).
- Direct experience in rare disease and/or gene therapy, gene editing, or advanced biologics strongly preferred.
- Demonstrated CRO/vendor oversight experience in global trials.
- Strong knowledge of ICH/GCP, FDA/CFR regulations, CDISC standards, and eCTD submission requirements.
- Experience with EDC systems, medical coding (MedDRA/WHO Drug), and external data integration.
- Strong understanding of safety data reconciliation and regulatory inspection preparedness.
- Excellent organizational, project management, and communication skills.
Key Competencies
- Strategic thinker with strong execution skills.
- Detail-oriented with high standards for data quality and compliance.
- Collaborative and cross-functional mindset.
- Comfortable working in a dynamic, innovative biotech environment.
- Passion for advancing transformative therapies for patients with rare genetic diseases.
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
U.S. Pay Range $174,000—$212,000 USD
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
Company Overview:
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.
Position Overview
Prime Medicine is seeking an experienced Associate Director of Clinical Data Management to lead clinical data strategy and execution across gene editing programs from first-in-human studies through regulatory submission. This role will oversee all internal and external data management activities supporting INDs, CTAs, BLAs, and global regulatory filings. The ideal candidate has experience in rare disease clinical trials, vendor oversight, and complex biologic or gene therapy programs, and is comfortable operating in a fast-paced environment. This individual will ensure clinical data integrity, regulatory readiness, and high-quality execution across the development portfolio. This role reports to the Senior Director, Clinical Operations.
Key Responsibilities
Clinical Data Leadership:
- Lead all clinical data management activities across multiple programs from IND through BLA submission.
- Develop and execute data management strategies aligned with regulatory requirements both in the US/ex-US.
- Oversee CRF design, database build, edit checks, data review, coding, reconciliation, and database lock.
- Ensure implementation of CDISC standards (SDTM/ADaM) to support submission readiness.
- Support inspection readiness and maintain audit-ready documentation.
Vendor Oversight & Governance:
- Lead selection, oversight, and performance management of CRO and data management vendors.
- Manage vendor budgets, timelines, KPIs, and quality metrics.
- Oversee external data transfers and reconciliation processes (e.g., SAE, lab, PK and PD).
- Ensure change control, database archiving, and data governance processes are compliant and well documented.
Gene Therapy & Rare Disease Expertise:
- Oversee integration of complex data streams including:
- Genomic and sequencing data
- Biomarker and translational endpoints
- Immunogenicity and PK/PD
- Long-term follow-up safety data
- Support dose-escalation studies with rapid data review cycles and SRC/DMC readiness.
- Tailor data processes to rare disease trial realities (small populations, adaptive designs, multi-cohort studies).
Systems & Infrastructure:
- Contribute to scalable data infrastructure and identification of key efficiencies between programs.
- Support implementation and optimization of EDC, ePRO, IRT, and data visualization systems.
- Ensure integration between clinical data, laboratory systems, and sample tracking systems.
Cross-Functional Collaboration:
- Partner with Clinical Development, Clinical Operations, Regulatory, Quality, and Translational Sciences.
- Serve as subject matter expert for data standards, governance, and process improvement initiatives.
- Contribute to development and improvement of internal SOPs and workflows.
Qualifications
- Bachelor’s degree in life sciences, statistics, informatics, or related field (advanced degree preferred).
- 8+ years of progressive clinical data management experience, including leadership responsibility.
- Experience supporting IND submissions and major regulatory filings (BLA/NDA/MAA).
- Direct experience in rare disease and/or gene therapy, gene editing, or advanced biologics strongly preferred.
- Demonstrated CRO/vendor oversight experience in global trials.
- Strong knowledge of ICH/GCP, FDA/CFR regulations, CDISC standards, and eCTD submission requirements.
- Experience with EDC systems, medical coding (MedDRA/WHO Drug), and external data integration.
- Strong understanding of safety data reconciliation and regulatory inspection preparedness.
- Excellent organizational, project management, and communication skills.
Key Competencies
- Strategic thinker with strong execution skills.
- Detail-oriented with high standards for data quality and compliance.
- Collaborative and cross-functional mindset.
- Comfortable working in a dynamic, innovative biotech environment.
- Passion for advancing transformative therapies for patients with rare genetic diseases.
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
U.S. Pay Range $174,000—$212,000 USD
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
See all 404+ Clinical Data Management Jobs
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Get Access To All JobsTips for Finding Clinical Data Management Jobs
Target CROs and pharma companies first
Contract research organizations and large pharmaceutical companies sponsor the most Clinical Data Management visas. These employers have established immigration processes and often work with outside counsel, making the sponsorship conversation significantly more straightforward than at smaller biotech startups.
Align your degree to the role explicitly
Consular officers and USCIS adjudicators need to see a direct connection between your degree field and clinical data management. Degrees in bioinformatics, biostatistics, health informatics, or life sciences are strongest. A general business or unrelated degree will require careful documentation to support specialty occupation status.
Highlight CDISC and CDASH expertise
Knowledge of CDISC standards, CDASH, and clinical trial data standards like SDTM strengthens your H-1B petition by demonstrating the specialized, technical nature of the role. These credentials help employers argue the position requires a specific, highly specialized degree rather than any bachelor's degree.
Get your Medidata or Oracle Health Sciences certifications documented
Certifications in clinical data management platforms like Medidata Rave or Oracle Clinical reinforce that your role is a specialty occupation. Include these in your resume and ensure your employer references them in the job description submitted with your LCA and I-129 petition.
Understand the LCA prevailing wage requirement
Your employer must file a Labor Condition Application certifying your offered compensation meets the prevailing wage for clinical data management in your work location. Remote roles can complicate this if your employer's headquarters and your actual work location are in different metropolitan areas with different wage levels.
Ask about cap-exempt sponsorship pathways
If you're in the H-1B lottery backlog, consider roles at hospitals, academic medical centers, or nonprofit research institutions. These employers are cap-exempt, meaning they can file H-1B petitions year-round without waiting for the annual lottery, which is particularly valuable in clinical research settings.
Frequently Asked Questions
Does Clinical Data Management qualify as an H-1B specialty occupation?
Yes, clinical data management qualifies as a specialty occupation when the role requires a bachelor's degree or higher in a specific field such as biostatistics, bioinformatics, health informatics, or life sciences. USCIS looks at whether the degree requirement is specific to the field, not just any bachelor's degree. Roles involving CDISC standards, clinical trial data oversight, and regulatory submission data have a stronger specialty occupation argument than general data entry or coordination positions.
Which employers are most likely to sponsor a Clinical Data Manager?
Large pharmaceutical companies, contract research organizations, and academic medical centers sponsor the most clinical data management roles. CROs in particular, including those running multinational Phase II and Phase III trials, have established immigration pipelines. Smaller biotechs may sponsor but often lack in-house immigration counsel, which can slow the process. Migrate Mate filters sponsorship-open CDM roles so you can focus on employers already set up to sponsor.
Can I get sponsored for a Clinical Data Management role on an OPT or STEM OPT extension?
Yes. If your degree is in a qualifying STEM field, such as bioinformatics, biostatistics, or health informatics, you may be eligible for a 24-month STEM OPT extension, giving you up to three years of work authorization after graduation. That additional runway is enough time to go through one or two H-1B lottery cycles. Make sure your employer is registered with E-Verify, which is required for STEM OPT.
What happens to my visa sponsorship if I switch from one CDM employer to another?
If you're on H-1B status, you can begin working for a new employer as soon as they file a new H-1B petition on your behalf, thanks to H-1B portability. You don't need to wait for USCIS approval before starting. However, the new employer must file before your current status expires, and the new role must also qualify as a specialty occupation. Keep copies of all your previous petitions and approval notices.
Is a master's degree required to get sponsored for Clinical Data Management, or is a bachelor's sufficient?
A bachelor's degree in a relevant field is generally sufficient for H-1B sponsorship in clinical data management. However, if your bachelor's is in an unrelated discipline, employers can sometimes substitute equivalent experience using the three-for-one rule, where three years of specialized work experience replaces one year of formal education. A master's degree in biostatistics or health informatics strengthens your petition and may open senior roles that have clearer specialty occupation arguments.
What is the prevailing wage requirement for sponsored Clinical Data Management jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.