H-1B Visa Clinical Data Management Jobs
Clinical Data Management roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in life sciences, bioinformatics, or a related field. Pharmaceutical companies, CROs, and biotech firms regularly sponsor H-1B workers for CDM positions, filing LCAs under SOC codes tied to data science and medical records management.
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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 68+ H-1B Visa Clinical Data Management Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Clinical Data Management Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Clinical Data Management
Align your credentials to SOC codes
Clinical Data Management roles are filed under SOC codes like 15-2051 or 29-2071. Check O*NET to confirm which code matches your specific duties, then ensure your resume and degree documentation reflect that occupational definition clearly.
Target CROs and pharma over startups
Contract Research Organizations and established pharmaceutical companies maintain dedicated immigration teams and file H-1B petitions annually. They're structurally set up to sponsor, unlike early-stage biotech firms that may lack the infrastructure to navigate USCIS requirements.
Search employer LCA filings on Migrate Mate
Filter by CDM-related job titles and SOC codes to see which companies have certified LCAs with DOL. This shows you active sponsors before you apply, so you're not guessing at a company's willingness to file.
Request the prevailing wage tier upfront
Your employer must certify your wage meets the DOL prevailing wage for your area and SOC code. Use the OFLC Wage Search to look up Level I through Level IV wages before negotiating, so you know whether an offer is likely to pass LCA certification.
Prepare clinical systems documentation early
USCIS often issues RFEs for CDM roles questioning whether the position qualifies as a specialty occupation. Gather evidence that your role requires specific degree-level knowledge in clinical data standards like CDISC, EDC systems, or 21 CFR Part 11 compliance.
Clarify cap-exempt status with academic medical centers
If you receive an offer from a university hospital or nonprofit research institution affiliated with a university, your employer may qualify as cap-exempt. That means no lottery, no October 1 start date, and the ability to file and begin work at any time of year.
H-1B Visa Clinical Data Management: Frequently Asked Questions
Does a Clinical Data Management role qualify as an H-1B specialty occupation?
Yes. Clinical Data Management qualifies as a specialty occupation because the role typically requires a bachelor's degree or higher in life sciences, bioinformatics, health informatics, or a directly related field. USCIS evaluates whether the specific duties require that theoretical and practical application of highly specialized knowledge, so your job description needs to clearly reflect degree-level responsibilities like CDISC standards implementation or clinical database design.
Which employers sponsor H-1B visas for Clinical Data Management jobs?
Pharmaceutical companies, contract research organizations, and large academic medical centers are the most consistent H-1B sponsors for CDM roles. These employers file LCAs with DOL annually and maintain immigration infrastructure. You can search employer filing history by job title and SOC code on Migrate Mate to identify companies that have actively sponsored CDM positions rather than relying on job postings alone.
What SOC code is used for H-1B filings in Clinical Data Management?
Most Clinical Data Management roles are filed under SOC 15-2051 (Data Scientists) or 29-2071 (Medical Records Specialists), depending on the role's primary duties. Some employers use 15-1211 (Computer Systems Analysts) for data management positions with heavy systems focus. The SOC code your employer selects determines the prevailing wage level DOL requires, so it directly affects your certified salary floor.
Can a Clinical Data Manager on OPT bridge to H-1B without a gap in work authorization?
Yes, if your employer files your H-1B petition before your OPT expires and you're selected in the lottery. The cap-gap rule automatically extends your OPT authorization through September 30 if your petition is pending or approved. If you're on STEM OPT, your 24-month extension gives you additional time, but you still need to be selected in the lottery and have your petition filed on time.
Do Clinical Data Management roles at CROs count toward H-1B specialty occupation requirements?
Generally yes, but the specific duties matter. USCIS looks at whether the position requires a degree in a specific field, not just any bachelor's degree. CRO-based CDM roles that involve protocol deviation review, EDC system configuration, or regulatory submission data packages are well-positioned. Generic data entry or project coordination duties that don't require specialized knowledge are more likely to draw an RFE, so the job description needs to be precise.