H-1B Visa Associate Director Clinical Data Management Jobs
Associate Director Clinical Data Management roles qualify as H-1B visa specialty occupations under USCIS guidelines, requiring at least a bachelor's degree in a directly related field. Sponsors file the LCA with DOL before petitioning, and most large CROs and pharma companies have established H-1B visa filing programs for this level.
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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 H-1B Visa Associate Director Clinical Data Management Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Associate Director Clinical Data Management
Verify your degree aligns with the role
USCIS scrutinizes degree-to-job fit for CDM director-level roles. A degree in biostatistics, health informatics, or life sciences maps cleanly. A general business degree may trigger an RFE, so gather transcripts and a credential evaluation before applying.
Target CROs and mid-size pharma sponsors
Contract research organizations and mid-size pharmaceutical companies file H-1B petitions for CDM leadership positions more consistently than small biotech startups. Search Migrate Mate to filter employers by verified LCA filing history for this specific role.
Check prevailing wage before negotiating offers
Your employer must certify your salary meets the DOL prevailing wage for your location and job level. Run your title and metropolitan area through the OFLC Wage Search before salary discussions to avoid offers that can't clear LCA certification.
Document CDISC and regulatory experience explicitly
H-1B petitions for CDM roles benefit from evidence tying your credentials to specialty occupation standards. Highlight CDISC CDASH and SDTM expertise, FDA submission experience, and any 21 CFR Part 11 compliance work in your resume and support letters.
Time your petition to avoid cap-gap gaps
If you're on OPT, your employer must file by April 1 for an October 1 start. A gap between OPT expiration and H-1B activation can disqualify you from continuing work. Confirm your employer's internal filing deadlines at least 90 days before your EAD expires.
Request premium processing for director-level offers
USCIS premium processing adjudicates the I-129 petition within 15 business days. At the Associate Director level, employers are often willing to pay for this, and it removes uncertainty during onboarding timelines for projects with fixed study startup dates.
H-1B Visa Associate Director Clinical Data Management: Frequently Asked Questions
Does an Associate Director Clinical Data Management role qualify as an H-1B specialty occupation?
Yes. Associate Director CDM roles require at least a bachelor's degree in a directly related field such as biostatistics, health informatics, computer science, or a life science. USCIS defines specialty occupation as a role where that specific degree is a minimum requirement, not merely preferred, and CDM director-level positions consistently meet that standard based on the technical and regulatory expertise required.
Which employers regularly sponsor H-1B visas for CDM director roles?
Large contract research organizations, top-50 pharmaceutical companies, and mid-size biotech firms with active clinical pipelines are the most consistent H-1B sponsors for CDM leadership positions. You can browse employers with verified LCA filing history for this role on Migrate Mate, which filters listings by actual DOL Labor Condition Application data rather than self-reported sponsorship policies.
What documents should I prepare before applying for CDM director roles as an H-1B candidate?
Prepare a credential evaluation if your degree is from outside the U.S., official transcripts, and a detailed resume that maps your experience to CDISC standards, FDA regulatory submissions, and any therapeutic area specializations. For the H-1B petition itself, your employer will also need a specialty occupation support letter and evidence that your role requires the specific degree USCIS scrutinizes at this seniority level.
How does the DOL prevailing wage requirement affect CDM director H-1B offers?
Your employer must file an LCA certifying that your offered salary meets or exceeds the DOL prevailing wage for your job title and work location before submitting the H-1B petition to USCIS. Offers below the prevailing wage cannot be certified, and the wage level assigned reflects your supervisory scope and years of experience. Use the OFLC Wage Search to look up the applicable wage before entering salary negotiations.
Can I switch employers as an H-1B holder in a CDM director role?
Yes, under H-1B portability rules established by AC21, you can start working for a new employer as soon as they file an H-1B transfer petition with USCIS, as long as your current H-1B status is valid and the new role is in the same or a similar occupational classification. You don't need to wait for USCIS to approve the transfer before starting, but your new employer must file promptly and the role must remain a specialty occupation.