Green Card Clinical Data Management Jobs
Clinical Data Management roles at biotech, pharma, and CRO employers qualify for EB-2 and EB-3 green card sponsorship through PERM labor certification. Employers file with DOL to verify no qualified U.S. workers are available, then petition USCIS for permanent residency. Processing runs 18 to 36 months for most countries, making early sponsorship conversations essential.
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Get Access To All JobsINTRODUCTION
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
JOB DESCRIPTION SUMMARY
The Senior Manager, Clinical Data Management is responsible for providing oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position is responsible for database development, utilizing EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position may have oversight responsibilities of external consultants. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated Quality Assurance/ Quality Control (QA/QC) Documentation. She/He will work cross-functionally with internal departments and external resources on Data Management related issues. The Senior Manager, Clinical Data Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary Duties/responsibilities
The successful candidate must be able to perform each of the following:
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Work closely with clinical research organizations (CROs) to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
- Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop clinical report forms (CRF's) to ensure the required information is captured for statistical analysis.
- Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development, and reviewing and processing clinical trial data to ensure completeness, accuracy, and consistency of clinical trials databases.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
- Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
- Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Manage multiple and varied tasks, prioritize workload with attention to detail.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
- Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
- Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
- Contribute to development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
- Minimum level of education and years of relevant work experience.
- Bachelor’s degree in science or related field (such as healthcare) with a minimum of 7 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
- Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies.
- Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
- Knowledge of industry standards, such as the ICH guidelines, 21 CFR Part 11, and FDA guidelines.
- MedDRA and WHO Drug coding proficiency is preferred.
- Experience with Medidata RAVE is desired.
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.).
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC and SDTM knowledge and experience are preferable.
- Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills.
- Technical skills and experience using Medidata or relational databases (e.g., Oracle InForm, MS SQL Server or MS Access) and data visualization tools (e.g., Spotfire, J-Review).
- Proficiency in the use of Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
TRAVEL REQUIREMENTS
- Up to 20%
EXPECTED BASE SALARY RANGE
$129,500 - $163,100. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
EEO STATEMENT
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
INTRODUCTION
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
JOB DESCRIPTION SUMMARY
The Senior Manager, Clinical Data Management is responsible for providing oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position is responsible for database development, utilizing EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position may have oversight responsibilities of external consultants. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated Quality Assurance/ Quality Control (QA/QC) Documentation. She/He will work cross-functionally with internal departments and external resources on Data Management related issues. The Senior Manager, Clinical Data Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary Duties/responsibilities
The successful candidate must be able to perform each of the following:
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Work closely with clinical research organizations (CROs) to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
- Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop clinical report forms (CRF's) to ensure the required information is captured for statistical analysis.
- Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development, and reviewing and processing clinical trial data to ensure completeness, accuracy, and consistency of clinical trials databases.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
- Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
- Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Manage multiple and varied tasks, prioritize workload with attention to detail.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
- Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
- Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
- Contribute to development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
- Minimum level of education and years of relevant work experience.
- Bachelor’s degree in science or related field (such as healthcare) with a minimum of 7 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
- Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies.
- Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
- Knowledge of industry standards, such as the ICH guidelines, 21 CFR Part 11, and FDA guidelines.
- MedDRA and WHO Drug coding proficiency is preferred.
- Experience with Medidata RAVE is desired.
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.).
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC and SDTM knowledge and experience are preferable.
- Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills.
- Technical skills and experience using Medidata or relational databases (e.g., Oracle InForm, MS SQL Server or MS Access) and data visualization tools (e.g., Spotfire, J-Review).
- Proficiency in the use of Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
TRAVEL REQUIREMENTS
- Up to 20%
EXPECTED BASE SALARY RANGE
$129,500 - $163,100. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
EEO STATEMENT
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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Get Access To All JobsTips for Finding Green Card Sponsorship in Clinical Data Management
Align your credentials to EB-2 or EB-3
EB-2 requires an advanced degree or its equivalent in a relevant field like biostatistics or clinical informatics. EB-3 covers bachelor's-level CDM professionals. Clarifying your tier before applying shapes which employers to target and what documentation your PERM file needs.
Target employers with active PERM histories
Pharma sponsors, large CROs, and academic medical centers file PERM most frequently for CDM roles. Search OFLC disclosure data by SOC code 15-2041 or job title to identify employers who have sponsored data management positions in the past two years.
Surface sponsoring employers through Migrate Mate
Filter by green card sponsorship history and CDM-specific job titles on Migrate Mate to avoid roles that will never lead to a PERM filing. This saves months of applications to employers who lack the infrastructure or intent to sponsor permanent residency.
Raise sponsorship timing in second-round interviews
Most CDM employers won't volunteer PERM timelines unprompted. After a technical screen, ask directly whether the role is eligible for employment-based green card sponsorship and what the company's typical PERM filing lag is after hiring.
Protect your PERM file with accurate job duties
DOL audits CDM PERM applications when job descriptions are overly generic or list duties that don't match the offered role. Work with your employer to ensure the PWD request and recruitment documentation reflect your actual day-to-day responsibilities, not a template.
Start the prevailing wage step as early as possible
PERM begins with a prevailing wage determination submitted to DOL, which can take several months. Use the OFLC Wage Search to benchmark your offered salary against Level I through IV wage data for your work location before your employer submits the PWD request.
Green Card Clinical Data Management: Frequently Asked Questions
Do Clinical Data Management roles qualify for EB-2 or EB-3 green card sponsorship?
Both categories apply depending on your credentials. EB-3 covers CDM professionals with a bachelor's degree in a relevant field such as life sciences, health informatics, or computer science. EB-2 applies if you hold a master's degree or higher, or can demonstrate the equivalent through a combination of education and progressive experience. Your employer petitions USCIS under whichever category fits your qualifications.
How does PERM green card sponsorship differ from H-1B for a CDM professional?
H-1B visa is a temporary work visa renewed in three-year increments with an annual lottery. PERM leads to lawful permanent residency with no cap concerns at the EB-3 level for most countries outside India and China. The PERM process is longer, typically 18 to 36 months from labor certification through I-485 approval, but the outcome is permanent status rather than repeated renewals.
Which employers sponsor green cards for Clinical Data Management jobs?
Pharmaceutical companies, contract research organizations, academic medical centers, and large health technology firms file PERM most frequently for CDM roles. You can search OFLC disclosure data filtered by job title or SOC code to identify employers with recent sponsorship history. Migrate Mate also lets you filter open CDM roles specifically by green card sponsorship intent, so you're only applying to positions where a PERM filing is a real possibility.
Can I switch CDM employers while my green card application is pending?
Portability under AC21 allows you to change to a same or similar occupation once your I-485 has been pending for 180 days or more. Clinical Data Management roles generally fall under a narrow SOC code, so confirm with your new employer that the offered position matches your original PERM job description closely enough to satisfy USCIS portability criteria before accepting an offer.
What documentation should I gather before a CDM employer starts my PERM filing?
You'll need official transcripts showing your degree in a qualifying field, any professional certifications such as CCDM or RAC, and documentation of foreign work experience if your employer needs to support an EB-2 advanced-degree equivalent claim. Organize these before your employer submits the prevailing wage determination to DOL, since delays in document collection can push back the entire PERM timeline by months.