Clinical Data Specialist Jobs in USA with Visa Sponsorship
Clinical Data Specialists are consistently sponsored for H-1B visas, with the role qualifying as a specialty occupation requiring a bachelor's degree in life sciences, statistics, or a related field. Employers across pharma, biotech, and CROs file petitions regularly for this title. For detailed occupation requirements, see the O*NET profile.
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Location: Libertyville
Department: Clinical Affairs
Summary
The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.
Responsibilities
Design and Planning
- Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
- Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements.
- Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives.
- Participate in study team meetings.
EDC Administration
- Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol.
- Lead User Acceptance Testing (UAT) to validate build specifications.
- Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed.
- Lead database clean, lock, export, and archiving activities.
- Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks.
- Continuously assess and enhance the EDC systems to improve efficiency and data quality.
Data Monitoring
- Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan.
- Coordinates AE/DD reconciliation with PI.
- Identify and communicate data issues and/or query trends to study team and/or management.
- Assist with developing metrics on study progress and routinely report out to study team and management.
Compliance and Process
- Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
- Contribute to the maintenance of GCA’s data management procedures and work instructions.
- Responsible for leading or collaborating on process improvement initiatives within department.
- Meet study timelines with a high degree of quality.
- Other duties as needed or required.
Essential Functions of the Role
- Communicate effectively via email, phone, and virtual platforms.
- Prepare reports and dashboards for internal stakeholders.
- Ensure data accuracy and confidentiality in compliance with company and legal standards.
- Manage multiple priorities and deadlines in a fast-paced environment.
- Demonstrate initiative in identifying process improvements or automation opportunities.
- Serve as a point of contact for internal and external stakeholders.
- Resolve inquiries and issues with professionalism and discretion.
- Adhere to company policies, including those related to ADA, data privacy, and ethics.
- Maintain secure handling of sensitive information.
Education & Work Requirements
- Bachelor's Degree with 2-5 years of related experience.
Education & Work Preferences
- Minimum of 2 years EDC database programming and Data Monitoring experience.
- Minimum of 2 years medical device and/or pharmaceutical clinical research experience.
- Certified Clinical Data Manager (CCDM) via SCDM or similar preferred.
- Equivalent combination of education, training and work experience may be accepted in lieu of degree.
- Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required.
- Understanding of clinical research regulations required.
- Experience in questionnaire development, database structure, and data management processes.
- Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams).
- Knowledge relating to continence care, critical care and/or ostomy a plus.
Competencies
- Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
- Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
- Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
- Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
- Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
Benefits Statement
Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
- The anticipated base pay range for this position is $77,000 - $120,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
- If applicable: This position is also eligible to participate in the Hollister Secure Start Bonus Plan.
- The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
- The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions.
- The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
- The Company’s additional benefits include: education assistance and adoption assistance benefit programs.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Req ID: 36304
We Make Life More Rewarding and Dignified
Location: Libertyville
Department: Clinical Affairs
Summary
The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.
Responsibilities
Design and Planning
- Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
- Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements.
- Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives.
- Participate in study team meetings.
EDC Administration
- Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol.
- Lead User Acceptance Testing (UAT) to validate build specifications.
- Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed.
- Lead database clean, lock, export, and archiving activities.
- Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks.
- Continuously assess and enhance the EDC systems to improve efficiency and data quality.
Data Monitoring
- Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan.
- Coordinates AE/DD reconciliation with PI.
- Identify and communicate data issues and/or query trends to study team and/or management.
- Assist with developing metrics on study progress and routinely report out to study team and management.
Compliance and Process
- Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
- Contribute to the maintenance of GCA’s data management procedures and work instructions.
- Responsible for leading or collaborating on process improvement initiatives within department.
- Meet study timelines with a high degree of quality.
- Other duties as needed or required.
Essential Functions of the Role
- Communicate effectively via email, phone, and virtual platforms.
- Prepare reports and dashboards for internal stakeholders.
- Ensure data accuracy and confidentiality in compliance with company and legal standards.
- Manage multiple priorities and deadlines in a fast-paced environment.
- Demonstrate initiative in identifying process improvements or automation opportunities.
- Serve as a point of contact for internal and external stakeholders.
- Resolve inquiries and issues with professionalism and discretion.
- Adhere to company policies, including those related to ADA, data privacy, and ethics.
- Maintain secure handling of sensitive information.
Education & Work Requirements
- Bachelor's Degree with 2-5 years of related experience.
Education & Work Preferences
- Minimum of 2 years EDC database programming and Data Monitoring experience.
- Minimum of 2 years medical device and/or pharmaceutical clinical research experience.
- Certified Clinical Data Manager (CCDM) via SCDM or similar preferred.
- Equivalent combination of education, training and work experience may be accepted in lieu of degree.
- Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required.
- Understanding of clinical research regulations required.
- Experience in questionnaire development, database structure, and data management processes.
- Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams).
- Knowledge relating to continence care, critical care and/or ostomy a plus.
Competencies
- Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
- Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
- Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
- Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
- Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
Benefits Statement
Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
- The anticipated base pay range for this position is $77,000 - $120,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
- If applicable: This position is also eligible to participate in the Hollister Secure Start Bonus Plan.
- The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
- The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions.
- The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
- The Company’s additional benefits include: education assistance and adoption assistance benefit programs.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Req ID: 36304
See all 31+ Clinical Data Specialist Jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a Clinical Data Specialist
Target CROs and pharma companies first
Contract research organizations and large pharmaceutical companies sponsor Clinical Data Specialists at the highest rates. These employers have established immigration infrastructure and file H-1B petitions routinely, making the process faster and more predictable than smaller employers.
Certify your degree aligns with the role
USCIS requires your degree to match the specialty occupation. A background in biostatistics, clinical research, life sciences, or health informatics strengthens your petition considerably. Generic degrees in business or unrelated fields raise specialty occupation challenges during adjudication.
Get clinical data system experience documented
Proficiency in Medidata Rave, Oracle Clinical, or Veeva Vault makes you more attractive to sponsors and supports your specialty occupation case. Document this experience clearly on your resume, as employers use it to justify the technical degree requirement.
Understand the LCA before accepting an offer
Your employer must file a Labor Condition Application with the Department of Labor before your H-1B petition. Ask whether the LCA has been certified before your start date, as delays here directly push back your authorization to work.
Ask employers about cap-exempt filing options
Some clinical data roles at hospitals, academic medical centers, or nonprofit research institutions qualify for cap-exempt H-1B petitions, bypassing the lottery entirely. If you have offers from these settings, prioritize them for a faster and more certain path.
Browse Migrate Mate for vetted sponsoring employers
Not every employer who lists a clinical data role will sponsor visas. Migrate Mate filters for employers with confirmed sponsorship history, saving you from applying to postings where sponsorship was never a realistic option.
Frequently Asked Questions
Does a Clinical Data Specialist role qualify as a specialty occupation for H-1B purposes?
Yes, Clinical Data Specialist consistently qualifies as a specialty occupation because the role requires specialized knowledge in clinical trial methodology, data management systems, and regulatory standards that is directly tied to a bachelor's degree or higher in a specific field. USCIS has approved H-1B petitions for this title across pharma and CRO employers with strong track records.
What degree do I need for an employer to sponsor me as a Clinical Data Specialist?
A bachelor's degree in biostatistics, clinical research, life sciences, health informatics, or a closely related field is the standard requirement. Some employers also accept computer science or data science degrees when the role focuses heavily on data systems and programming. A degree in an unrelated field weakens the specialty occupation argument and increases the risk of an RFE from USCIS.
Which types of employers are most likely to sponsor Clinical Data Specialists?
Large pharmaceutical companies, contract research organizations, biotechnology firms, and academic medical centers are the most active sponsors. CROs in particular hire Clinical Data Specialists in volume and have dedicated immigration teams that handle H-1B petitions routinely. Smaller startups or hospitals without established immigration infrastructure are less predictable. Migrate Mate lists employers in this space that have confirmed sponsorship histories.
Can I transfer my H-1B to a new employer if I change clinical data jobs?
Yes. Under H-1B portability, you can begin working for a new employer as soon as they file a transfer petition, without waiting for USCIS approval, as long as you have been in valid H-1B status and the petition is non-frivolous. The new employer must file their own I-129 and certified LCA. Your status does not reset, and your existing priority date carries over.
How does the H-1B lottery affect my chances of getting sponsored as a Clinical Data Specialist?
If your employer is subject to the H-1B cap, your petition enters the annual lottery, which selected roughly 25 percent of registrations in recent years. Cap-exempt employers, including universities and nonprofit research institutions, bypass the lottery entirely. If you did not get selected, E-3 visa applies only to Australians, and O-1 visa is an option for those with demonstrated exceptional achievement in clinical research.
What is the prevailing wage requirement for sponsored Clinical Data Specialist 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.