H-1B Visa Senior Clinical Data Manager Jobs
Senior Clinical Data Manager roles qualify as H-1B specialty occupations under USCIS criteria, requiring at least a bachelor's degree in life sciences, biostatistics, or a related field. Sponsors file an LCA with DOL before petitioning, and many CROs, biopharma companies, and academic medical centers have active H-1B filing histories for this role.
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INTRODUCTION
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate – enabling our life sciences clients to proactively manage their clinical programs and make decisions.
ROLE AND RESPONSIBILITIES
You will make an impact:
As a Senior Clinical Data Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior Clinical Data Manager, you may delegate tasks/responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables.
Your day to day:
- Primary representative for eClinical Solutions and sponsor data management interaction
- Responsible for monitoring and ensuring adherence to study timelines and deliverables
- Accountable for the overall quality of data management activities and deliverables at the study or program level
- Ensure efficiency and consistency for data management tasks across programs
- Communicate with global study teams
- Participate in client study kickoff and closeout/lessons learned meetings
- Create materials for and present at Investigator Meetings
- Develop content and deliver Sponsor CRA and/or site training
- Delegate tasks, support and provide guidance to study data management team
- Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text
- Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications
- Participate in Internal System Testing (IST) on the database/user roles/edit check specifications
- Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting
- Utilization of centralized data management platform including graphical patient profiles and operational analytics
- Compile the sponsor UAT package
- Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications
- Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools
- Oversee and/or perform data review for overall consistency and accuracy
- Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database
- Oversee and/or perform query processing/resolution
- Provide ongoing data management reports and metrics
- Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study
- Define and develop specifications for database, programming and/or edit check changes as needed throughout the study
- Track data management issues and ensure follow up to resolution
- Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan
- Maintain data management study documentation
- Perform steps pertaining to database freeze/lock and coordinate all related activities
- Ongoing evaluation of process and participate in process improvement
- Assist in the creation and review of SOPs, WIs, and training materials
- Mentor junior level staff and peers on all associated tasks within a study
- Participate in proposal defenses
- Perform other duties as requested by management
BASIC QUALIFICATIONS
Qualifications:
- Bachelor's degree in Pharmaceutical/Biotechnology or higher in health-related field preferred
- 8+ years in Clinical Data Management experience preferred
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology
- Strong project management experience and project team leadership skills including work planning and work delegation
- Experience with EDC and performing data management activities
- Excellent verbal and written communication skills
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Experience with EDC and Clinical Data Management Systems
COMPENSATION
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance.
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Senior Clinical Data Manager
Map your degree to specialty occupation criteria
USCIS requires your degree field to directly relate to clinical data management. A biostatistics, life sciences, or health informatics degree strengthens your petition. If your degree is adjacent, document how your coursework aligns with CDM-specific duties like CDASH compliance and database validation.
Filter employers by LCA filing history
Use Migrate Mate to search for employers with verified LCA filings for clinical data manager roles. Sponsors who have filed before understand the process and are far less likely to withdraw an offer once they see USCIS timelines for H-1B adjudication.
Target CROs and biopharma over staffing agencies
Contract research organizations and mid-to-large biopharma companies file H-1B petitions as direct employers, which avoids the third-party placement complications that USCIS scrutinizes heavily in consulting arrangements. Look for roles with a defined worksite and internal team structure.
Verify the prevailing wage tier before accepting an offer
DOL assigns CDM roles to wage levels based on experience and supervision. Use the OFLC Wage Search to confirm your offered salary meets at least Level II or III for your metro area before the LCA is filed, since underpayment can delay or invalidate certification.
Request premium processing if your OPT cap-gap is tight
If you're transitioning from F-1 OPT, premium processing reduces USCIS adjudication to 15 business days. For senior-level CDM roles with October 1 start dates, a delayed approval can disrupt clinical trial timelines and give employers reason to rescind offers.
Document CDISC and 21 CFR Part 11 expertise explicitly
H-1B petitions for CDM roles benefit from evidence that the position requires specialized knowledge. Your CV and employer support letter should call out CDISC standards, regulatory submission experience, and validation protocols to reinforce the specialty occupation argument USCIS applies.
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Find Senior Clinical Data Manager JobsSenior Clinical Data Manager H-1B Visa: Frequently Asked Questions
Does a Senior Clinical Data Manager role qualify as an H-1B specialty occupation?
Yes. USCIS evaluates whether the role normally requires at least a bachelor's degree in a specific field. Senior CDM positions routinely require degrees in biostatistics, clinical research, health informatics, or life sciences, and the job duties tied to CDISC compliance, database validation, and regulatory submissions strongly support the specialty occupation argument.
Which types of employers sponsor H-1B visas for clinical data manager roles?
Contract research organizations, biopharma and biotech companies, academic medical centers, and medical device manufacturers are the most active H-1B sponsors for CDM roles. Staffing or consulting firms can also sponsor, but USCIS applies additional scrutiny to third-party placements. You can browse verified H-1B sponsoring employers on Migrate Mate by role and location.
How does the H-1B prevailing wage requirement apply to senior CDM positions?
DOL requires your employer to certify on the LCA that your offered salary meets the prevailing wage for the role and location. Senior CDM roles typically fall at wage Level III or IV given the supervisory responsibilities and specialized knowledge involved. You can verify the applicable wage tier using the OFLC Wage Search before your employer files the LCA.
Can I switch employers on an H-1B if a better CDM role becomes available?
Yes, H-1B portability under AC21 allows you to change employers once your petition has been filed and you've maintained valid status. Your new employer must file an H-1B transfer petition before your current status expires. You can start the new CDM role as soon as the transfer petition is received by USCIS, not when it's approved.
Does clinical data management experience outside the U.S. count toward H-1B eligibility?
Foreign work experience in clinical data management can satisfy the specialty occupation requirement, particularly when it involved regulatory submissions, CDISC standards, or oversight of data management teams. Your employer's H-1B support letter should document how that experience is equivalent to U.S. CDM practice at a senior level, which USCIS will evaluate during adjudication.
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