H-1B Visa Senior Clinical Data Manager Jobs
Senior Clinical Data Manager roles qualify as H-1B visa 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 visa filing histories for this role.
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Get Access To All JobsPosition Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to:
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- May perform quality control of data entry
- Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
- May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation
- Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
- May review Request for Proposals (RFP), proposals, provide project estimates
- Provide leadership for cross-functional and organization-wide initiatives, where applicable
- Trains and ensures that all data management project team members have been sufficiently trained
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
- May present software demonstrations/trainings, department/company training sessions, present at project meetings
- May require some travel
- Perform other duties as assigned
Qualifications
Minimum Required:
- Bachelors and/or a combination of related experience
Other Required:
- 8+ years' experience as a Sr. Clinical Data Manager and 5 Years as a Clinical Data Manager II
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
Preferred:
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Oncology and/or Orphan Drug therapeutic experience
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to:
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- May perform quality control of data entry
- Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
- May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation
- Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
- May review Request for Proposals (RFP), proposals, provide project estimates
- Provide leadership for cross-functional and organization-wide initiatives, where applicable
- Trains and ensures that all data management project team members have been sufficiently trained
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
- May present software demonstrations/trainings, department/company training sessions, present at project meetings
- May require some travel
- Perform other duties as assigned
Qualifications
Minimum Required:
- Bachelors and/or a combination of related experience
Other Required:
- 8+ years' experience as a Sr. Clinical Data Manager and 5 Years as a Clinical Data Manager II
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
Preferred:
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Oncology and/or Orphan Drug therapeutic experience
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
See all H-1B Visa Senior Clinical Data Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Senior Clinical Data Manager Jobs.
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.
H-1B Visa Senior Clinical Data Manager: 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.