Senior Clinical Data Manager Jobs in USA with Visa Sponsorship
Senior Clinical Data Manager roles qualify as specialty occupations under the H-1B visa, making employer sponsorship straightforward for candidates with a relevant degree. Pharma and CRO employers file LCAs regularly for this title, and EB-2 or EB-3 green card paths are common given the advanced degree requirements. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Position Summary
The Senior Manager, Clinical Data is the sponsor's data management lead for every company-sponsored study, across Clinical Development and Medical Affairs. Data management is outsourced to CROs and specialty vendors; this role sets standards, oversees vendor delivery and owns sponsor accountability for data quality from database design through lock. The role works hand in hand with study leads and the Biostatistician so data are fit for analysis, submission and publication.
DUTIES AND RESPONSIBILITIES:
- Lead sponsor review and approval of data management plans, eCRF design, edit check specifications, data review plans and data transfer agreements.
- Oversee EDC build and participate in user acceptance testing; approve go-live.
- Monitor CRO data management performance against KPIs: query aging, data entry timeliness, open discrepancies and cleaning status.
- Own database lock readiness: lock checklists, reconciliation sign-off and sponsor approval to lock.
- Oversee integration and reconciliation of external data (central lab, IRT, eCOA/ePRO, imaging, biomarker) and SAE reconciliation with Safety.
- Oversee medical coding (MedDRA, WHODrug) with Clinical Science and Medical review.
- Partner with study leads and Clinical Science on ongoing clinical data review, listings and trend detection as part of risk-based quality management.
- Drive consistent data standards across the portfolio (CDASH collection, CDISC SDTM oversight) and reusable eCRF and edit-check libraries.
- Define data collection for Phase 3b/4, registry and chart review studies: abstraction forms, data dictionaries, source data quality checks and transfer specifications, proportionate to study risk.
- Ensure data management TMF artifacts are complete and current; support audits and inspections on data handling and computerized system validation.
- Contribute to vendor selection for CROs, EDC and specialty data vendors.
- Other duties as assigned.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in life sciences, health informatics, computer science or related field.
- 7+ years in clinical data management.
- Hands-on experience with major EDC platforms (e.g. Medidata Rave, Veeva CDMS) and external data reconciliation.
- Working knowledge of CDISC (CDASH, SDTM), MedDRA/WHODrug coding, ICH E6(R3) and 21 CFR Part 11.
- Experience taking studies through database lock and supporting a regulatory submission; RWE or observational study experience valued.
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
INTRODUCTION
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Position Summary
The Senior Manager, Clinical Data is the sponsor's data management lead for every company-sponsored study, across Clinical Development and Medical Affairs. Data management is outsourced to CROs and specialty vendors; this role sets standards, oversees vendor delivery and owns sponsor accountability for data quality from database design through lock. The role works hand in hand with study leads and the Biostatistician so data are fit for analysis, submission and publication.
DUTIES AND RESPONSIBILITIES:
- Lead sponsor review and approval of data management plans, eCRF design, edit check specifications, data review plans and data transfer agreements.
- Oversee EDC build and participate in user acceptance testing; approve go-live.
- Monitor CRO data management performance against KPIs: query aging, data entry timeliness, open discrepancies and cleaning status.
- Own database lock readiness: lock checklists, reconciliation sign-off and sponsor approval to lock.
- Oversee integration and reconciliation of external data (central lab, IRT, eCOA/ePRO, imaging, biomarker) and SAE reconciliation with Safety.
- Oversee medical coding (MedDRA, WHODrug) with Clinical Science and Medical review.
- Partner with study leads and Clinical Science on ongoing clinical data review, listings and trend detection as part of risk-based quality management.
- Drive consistent data standards across the portfolio (CDASH collection, CDISC SDTM oversight) and reusable eCRF and edit-check libraries.
- Define data collection for Phase 3b/4, registry and chart review studies: abstraction forms, data dictionaries, source data quality checks and transfer specifications, proportionate to study risk.
- Ensure data management TMF artifacts are complete and current; support audits and inspections on data handling and computerized system validation.
- Contribute to vendor selection for CROs, EDC and specialty data vendors.
- Other duties as assigned.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in life sciences, health informatics, computer science or related field.
- 7+ years in clinical data management.
- Hands-on experience with major EDC platforms (e.g. Medidata Rave, Veeva CDMS) and external data reconciliation.
- Working knowledge of CDISC (CDASH, SDTM), MedDRA/WHODrug coding, ICH E6(R3) and 21 CFR Part 11.
- Experience taking studies through database lock and supporting a regulatory submission; RWE or observational study experience valued.
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Senior Clinical Data Manager
Align your degree to CDM requirements
H-1B specialty occupation requires a bachelor's or higher in a directly related field. Life sciences, bioinformatics, statistics, or health informatics degrees map cleanly to Senior CDM roles. A general business degree typically won't satisfy USCIS scrutiny without additional credentials.
Target CROs and pharma with active LCA filings
Contract research organizations and mid-to-large pharmaceutical sponsors file LCAs consistently for clinical data management titles. Search OFLC public disclosure data to verify which employers have certified LCAs for this exact job title before you apply.
Get CCDM certification before interviewing
The Certified Clinical Data Manager credential strengthens your specialty occupation argument at the USCIS review stage. Employers in regulated trials increasingly list it as preferred, and it differentiates your petition if your degree is in a tangentially related field.
Find sponsors through Migrate Mate
Search Senior Clinical Data Manager roles on Migrate Mate to surface employers with verified LCA sponsorship history. This saves you from applying to companies that have never filed for this title and reduces time spent on dead-end outreach.
Request prevailing wage documentation early
Your employer must file an LCA certifying your salary meets the prevailing wage before USCIS can adjudicate your H-1B petition. Ask HR to run the OFLC Wage Search for your work location before an offer is finalized, so wage compliance doesn't delay your start date.
Front-load PERM preparation if targeting a green card
Many CROs sponsor EB-2 or EB-3 green cards for Senior CDMs given the specialized role requirements. PERM labor certification can take 12 to 18 months, so ask your employer to begin the process during your first H-1B term, not at renewal.
Frequently Asked Questions
Does a Senior Clinical Data Manager role qualify as a specialty occupation for H-1B purposes?
Yes. Senior Clinical Data Manager roles consistently meet USCIS's specialty occupation standard because they require a bachelor's degree or higher in a directly related field such as life sciences, bioinformatics, or health informatics. Employers regularly file H-1B petitions for this title, and the complexity of regulatory data standards in clinical trials supports the degree requirement argument.
Which visa types are realistic for Senior Clinical Data Manager candidates seeking sponsorship?
H-1B is the most common path for employer-sponsored CDMs. Australians can pursue the E-3 visa, which has no lottery and allows unlimited two-year renewals. TN visa is not applicable since Clinical Data Manager is not on the USMCA profession list. For long-term U.S. residence, EB-2 and EB-3 green card sponsorship through PERM is standard at pharmaceutical and CRO employers.
What degree does a Senior Clinical Data Manager need to qualify for visa sponsorship?
USCIS requires a bachelor's degree or higher in a field directly related to the role. Life sciences, bioinformatics, statistics, clinical research, or health informatics are the most defensible fields. If your degree is in a tangentially related area, a Certified Clinical Data Manager credential can strengthen the specialty occupation argument and reduce the risk of a Request for Evidence.
How do I find employers who actively sponsor Senior Clinical Data Manager roles?
Migrate Mate lists employers with verified LCA sponsorship history for clinical data management titles, so you can focus your search on companies that have already committed to sponsoring this role type rather than guessing at willingness during the interview process.
Can a Senior Clinical Data Manager pursue a green card while on an H-1B?
Yes. H-1B allows dual intent, meaning you can pursue an employer-sponsored green card while maintaining valid H-1B status without jeopardizing your nonimmigrant standing. Most sponsors use the EB-2 or EB-3 category, which requires PERM labor certification through DOL before USCIS adjudicates the I-140 petition. Starting PERM early in your first H-1B term avoids timing conflicts with extensions.
What is the prevailing wage requirement for sponsored Senior Clinical Data Manager 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.