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 JobsINTRODUCTION
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
ROLE
Senior Director, Clinical Data Management and Analytics, provides leadership to the Clinical Data Management and Analytics Department and provides influence across the Clinical Development organization. As a leader of the Clinical Data Management and Analytics organization, and part of a cross-functional team of drug development scientists focused on providing hands-on skills, expertise, and tools to facilitate strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials, in addition to integration, visualization, and exploratory analysis of complex and diverse data in support of clinical development activities and decisions. Through practical hands-on work, the Lead will define approaches, processes, algorithms, and tools that support the analytics, visualizations, and decision support needs of drug development scientists and projects. The Lead will play a key role in building the team with the necessary skills, build relationships with relevant stakeholders, and implement relevant tools and approaches. The Lead will collaborate with Biostatistics leads and other members of drug development teams to ensure connectivity of exploratory analysis work in support of development, regulatory approval, and market acceptance of products. This position includes functional management responsibilities.
Essential Functions and Responsibilities
- Define and implement the overall vision, strategy, and goals for the clinical data management department.
- Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
- Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
- Experience with global trials and regulatory submissions (FDA, EMA).
- Generate novel insights from data and present them via rich and intuitive visualizations.
- Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively across several teams with diverse subject matter expertise.
- Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
- Drives the development and implementation of innovative strategies and technologies.
- Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and build upon existing Iovance standards.
- Provides technical guidance to external partners concerning project and data standards, and analysis practices to ensure efficient and integrated project strategies.
- Identifies opportunities for increased efficiency and consistency within the organization and provides SME support to continuous improvement initiatives.
- Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Performs miscellaneous duties as assigned.
BASIC QUALIFICATIONS
- Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.
- Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
- Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
- Demonstrated ability to lead, motivate, and develop teams.
- Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
- Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
- MS, BS/BA degree, or other suitable qualification with relevance to the field.
- 13 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
- Excellent verbal and written communication skills and strong interpersonal skills are required.
- Demonstrated ability to develop and lead a team of individuals with diverse experience and expertise.
- Ability to explain technically complex information for a non-technical audience.
- Strong positive attitude, thrives in a dynamic, fast paced environment with many simultaneous projects.
- Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
PREFERRED QUALIFICATIONS
- Experience with AI applications in the data management space is highly desirable.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
LI-remote
INTRODUCTION
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
ROLE
Senior Director, Clinical Data Management and Analytics, provides leadership to the Clinical Data Management and Analytics Department and provides influence across the Clinical Development organization. As a leader of the Clinical Data Management and Analytics organization, and part of a cross-functional team of drug development scientists focused on providing hands-on skills, expertise, and tools to facilitate strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials, in addition to integration, visualization, and exploratory analysis of complex and diverse data in support of clinical development activities and decisions. Through practical hands-on work, the Lead will define approaches, processes, algorithms, and tools that support the analytics, visualizations, and decision support needs of drug development scientists and projects. The Lead will play a key role in building the team with the necessary skills, build relationships with relevant stakeholders, and implement relevant tools and approaches. The Lead will collaborate with Biostatistics leads and other members of drug development teams to ensure connectivity of exploratory analysis work in support of development, regulatory approval, and market acceptance of products. This position includes functional management responsibilities.
Essential Functions and Responsibilities
- Define and implement the overall vision, strategy, and goals for the clinical data management department.
- Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
- Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
- Experience with global trials and regulatory submissions (FDA, EMA).
- Generate novel insights from data and present them via rich and intuitive visualizations.
- Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively across several teams with diverse subject matter expertise.
- Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
- Drives the development and implementation of innovative strategies and technologies.
- Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and build upon existing Iovance standards.
- Provides technical guidance to external partners concerning project and data standards, and analysis practices to ensure efficient and integrated project strategies.
- Identifies opportunities for increased efficiency and consistency within the organization and provides SME support to continuous improvement initiatives.
- Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Performs miscellaneous duties as assigned.
BASIC QUALIFICATIONS
- Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.
- Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
- Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
- Demonstrated ability to lead, motivate, and develop teams.
- Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
- Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
- MS, BS/BA degree, or other suitable qualification with relevance to the field.
- 13 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
- Excellent verbal and written communication skills and strong interpersonal skills are required.
- Demonstrated ability to develop and lead a team of individuals with diverse experience and expertise.
- Ability to explain technically complex information for a non-technical audience.
- Strong positive attitude, thrives in a dynamic, fast paced environment with many simultaneous projects.
- Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
PREFERRED QUALIFICATIONS
- Experience with AI applications in the data management space is highly desirable.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
LI-remote
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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.
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Find Clinical Data Management JobsFrequently 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.
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