Green Card Associate Director Clinical Data Management Jobs
Associate Director Clinical Data Management roles qualify for EB-2 or EB-3 green card sponsorship through PERM labor certification, with employers documenting that no qualified U.S. worker is available for the position. Biopharma, CRO, and medical device companies routinely file I-140 petitions for CDM leaders overseeing trial data quality and regulatory submissions.
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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
Job Description
Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area.
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.
She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues.
The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- Ensure the data collected meets the requirements of the study objective and company quality standards.
- Assist in the development and implementation of strategic vision for data management (DM) group.
- Collaborate with 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 design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis.
- Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding.
- Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities.
- Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), 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.
- Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD) to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Mentor clinical team members by resolving problems and providing DM guidance.
- 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 the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
- May manage, coach, and mentor direct reports.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
- Bachelor’s degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
- Experience in second-line management and functional leadership.
- 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, CDASH, 21 CFR Part 11, and FDA guidelines.
- 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 verbal and written communication, decision-making, influencing, negotiation, and project management skills.
- Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects).
- Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.).
- Learning agility and ‘scalability’ to take on increasing responsibility.
- Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.
- Ability to influence without direct authority.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- 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.
KNOWLEDGE/SKILLS/ABILITIES PREFERRED
- Minimum five (5) years’ experience with Medidata RAVE (EDC, R2DS/RBS, Architect).
- Experience with Medidata RAVE.
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience.
- Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred.
Travel requirements
- 5-15%
Expected Base Salary Range
$163,800 - $206,200. 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
Job Description
Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area.
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.
She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues.
The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- Ensure the data collected meets the requirements of the study objective and company quality standards.
- Assist in the development and implementation of strategic vision for data management (DM) group.
- Collaborate with 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 design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis.
- Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding.
- Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities.
- Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), 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.
- Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD) to meet regulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Mentor clinical team members by resolving problems and providing DM guidance.
- 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 the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
- May manage, coach, and mentor direct reports.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
- Bachelor’s degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
- Experience in second-line management and functional leadership.
- 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, CDASH, 21 CFR Part 11, and FDA guidelines.
- 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 verbal and written communication, decision-making, influencing, negotiation, and project management skills.
- Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects).
- Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.).
- Learning agility and ‘scalability’ to take on increasing responsibility.
- Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.
- Ability to influence without direct authority.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- 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.
KNOWLEDGE/SKILLS/ABILITIES PREFERRED
- Minimum five (5) years’ experience with Medidata RAVE (EDC, R2DS/RBS, Architect).
- Experience with Medidata RAVE.
- Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience.
- Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred.
Travel requirements
- 5-15%
Expected Base Salary Range
$163,800 - $206,200. 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 Associate Director Clinical Data Management
Align your credentials with EB-2 requirements
An advanced degree in biostatistics, clinical informatics, or a related life sciences field strengthens EB-2 eligibility. If your master's is from outside the U.S., get a credential evaluation completed before targeting roles, since PERM audits can stall without recognized equivalency documentation.
Target CROs and biopharma over staffing firms
Contract research organizations and mid-to-large biopharma companies with established legal and HR infrastructure are most likely to sponsor PERM. Staffing agencies rarely initiate green card filings for contract-based CDM placements, so prioritize direct-hire postings with permanent employment language.
Search verified sponsors on Migrate Mate
Use Migrate Mate to filter Associate Director CDM openings by employers with active green card filing history. Seeing verified sponsorship data before applying saves time and avoids roles where sponsorship is mentioned in interviews but never materializes.
Understand how PERM job descriptions affect your case
The PERM application locks in the job duties DOL will audit. Employers write requirements narrowly to reflect your actual role, so negotiate your title and responsibilities before the recruitment period starts, not after the I-140 is filed.
Track priority dates for your country of birth
EB-2 and EB-3 priority dates matter most if you were born in India or China, where backlogs can extend years. Check the USCIS Visa Bulletin monthly and ask your employer's immigration counsel whether concurrent I-485 filing is available when you receive your I-140 approval.
Document your CDISC and 21 CFR Part 11 experience
PERM recruitment must show no minimally qualified U.S. worker was found. Demonstrating specialized experience with CDISC standards, regulatory submissions, or clinical data governance frameworks distinguishes your background and supports the employer's case that your skills match a legitimately specialized role.
Green Card Associate Director Clinical Data Management: Frequently Asked Questions
Does an Associate Director Clinical Data Management role qualify for EB-2 or EB-3 green card sponsorship?
Most Associate Director CDM positions qualify for EB-2 sponsorship because the role routinely requires a master's degree or equivalent in a life sciences or informatics field. Employers may also file under EB-3 if the position is structured as a bachelor's-plus-experience role. The classification depends on how the employer writes the PERM job requirements, not solely on your personal credentials.
How does PERM green card sponsorship differ from H-1B sponsorship for this role?
H-1B visa is a temporary work visa requiring renewal and subject to annual lottery uncertainty, while PERM is the first step toward permanent residency with no cap at the application stage. The PERM process requires a DOL-supervised recruitment period to demonstrate no qualified U.S. worker is available, which adds time upfront but leads to an I-140 immigrant petition and eventual lawful permanent residency rather than a renewable nonimmigrant status.
How long does the full EB-2 or EB-3 green card process typically take for a CDM director role?
The PERM labor certification stage alone averages over a year with DOL, and I-140 processing adds additional time. For applicants born in countries without significant visa backlogs, adjustment of status can follow relatively quickly after I-140 approval. Applicants born in India or China face priority date backlogs that can extend the total timeline by years, making early employer conversations about sponsorship timing critical.
Where can I find Associate Director CDM jobs where the employer has confirmed green card sponsorship?
Migrate Mate lets you search CDM leadership roles filtered by employers with documented green card filing history, so you're not relying on vague sponsorship language in job postings. Identifying sponsors before applying is especially useful at the director level, where negotiating PERM terms during the offer stage is far more effective than raising it after you've accepted.
Can I change employers during the green card process without starting over?
Once your I-140 has been approved and your priority date is more than 180 days old, you may be able to port your green card to a new employer in the same or similar occupational classification under AC21 portability rules. For Associate Director CDM roles, a new position in clinical data management at a comparable seniority level would generally qualify, but your immigration counsel should confirm the occupational match before you accept a new offer.