Associate Director Clinical Data Management Jobs in USA with Visa Sponsorship
Associate Director Clinical Data Management roles regularly attract H-1B visa sponsorship from large pharmaceutical companies, CROs, and biotech firms. A master's or doctoral degree in a life sciences or data field strengthens your case significantly, and USCIS consistently classifies this as a specialty occupation. For detailed occupation requirements, see the O*NET profile.
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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 8,181+ Associate Director Clinical Data Management Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Associate Director Clinical Data Management roles.
Get Access To All JobsTips for Finding Associate Director Clinical Data Management Jobs
Target CROs and large pharma first
Contract research organizations like IQVIA, Covance, and Parexel, along with large pharmaceutical companies, sponsor H-1B visas for this role far more frequently than smaller biotech startups. Their established immigration programs mean faster, more experienced processing.
Lead with your CDISC and CDASH expertise
Employers sponsoring this role want proof of technical depth. Highlighting hands-on experience with CDISC standards, CDASH, SDTM, and regulatory submission data packages signals the specialized knowledge that justifies both the hire and the sponsorship investment.
Show cross-functional leadership experience
Associate Director-level roles require managing clinical data teams, vendors, and study timelines simultaneously. Documenting specific examples where you led data management across Phase II or Phase III trials strengthens your sponsorship case at this seniority level.
Confirm your degree field aligns with the role
USCIS scrutinizes specialty occupation for CDM roles. A degree in biostatistics, life sciences, health informatics, or computer science directly supporting clinical data work typically satisfies the requirement. A general business degree alone may face a Request for Evidence.
Ask about sponsorship timeline during early interviews
H-1B cap-subject petitions are filed in April for October start dates. If you're interviewing in late summer or fall, ask whether the company will support a cap-exempt path or file in the next available lottery cycle to avoid gaps.
Highlight FDA and ICH regulatory experience explicitly
Experience preparing data for FDA submissions or ensuring compliance with ICH E6 Good Clinical Practice guidelines is particularly valued. Employers are more willing to sponsor candidates whose regulatory knowledge reduces trial risk and audit exposure.
Frequently Asked Questions
Do Associate Director Clinical Data Management roles typically get H-1B visa sponsorship?
Yes. This is a well-established specialty occupation under USCIS guidelines, and large pharmaceutical companies, CROs, and biotech firms regularly sponsor H-1B visa petitions for it. The role's degree requirements and technical complexity make it a strong fit for sponsorship. You can browse verified sponsoring employers on Migrate Mate.
What degree do I need for an Associate Director Clinical Data Management H-1B petition?
USCIS requires a bachelor's degree or higher in a directly related field. Biostatistics, health informatics, life sciences, pharmacology, or computer science all support a strong specialty occupation argument. A master's degree is common at this seniority level and reduces the likelihood of a Request for Evidence. General degrees without a clear connection to clinical data management may require additional documentation.
How does seniority affect H-1B approval for this role?
Associate Director-level positions generally face fewer RFEs than entry-level CDM roles because the scope of work, technical complexity, and managerial responsibility more clearly satisfy specialty occupation criteria. USCIS looks for evidence that the role requires at minimum a bachelor's degree in a specific field, and senior titles typically come with job descriptions that make that case more easily.
Can I transfer my H-1B to a new employer if I change CDM roles?
Yes. H-1B portability allows you to start working for a new employer as soon as they file a transfer petition, without waiting for approval, provided your current H-1B was previously approved and you've maintained valid status. The new employer must file a new I-129 petition, and the role must still qualify as a specialty occupation. Consult an immigration attorney before making the move.
Are there visa options beyond H-1B for this role?
Australian citizens can pursue the E-3 visa, which has no lottery and a dedicated annual allocation. Canadian and Mexican nationals may qualify under the TN visa category if the role maps to an eligible USMCA occupation. Individuals with an extraordinary record in clinical data management could explore the O-1A. Each path has different employer requirements and timelines, so the right option depends on your nationality and current status.
What is the prevailing wage requirement for sponsored Associate Director 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.