Regulatory Data Manager
Plano, TX ยท Remote
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... Work with clients' electronic trial master file systems to ensure all data management documentation ...
Plano, TX ยท Remote
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... Work with clients' electronic trial master file systems to ensure all data management documentation ...
Plano, TX ยท Remote
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... Work with clients' electronic trial master file systems to ensure all data management documentation ...
Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); * Collect, review, organize, and assemble regulatory start-up submissions (including submissions to ...
Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); * Collect, review, organize, and assemble regulatory start-up submissions (including submissions to ...
Plano, TX ยท On-site +1
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... trial master file systems to ensure all data management documentation is correctly formatted ...
Plano, TX ยท On-site +1
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... trial master file systems to ensure all data management documentation is correctly formatted ...
Plano, TX ยท Remote
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... trial master file systems to ensure all data management documentation is correctly formatted ...
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Plano, TX ยท Remote
Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data ... trial master file systems to ensure all data management documentation is correctly formatted ...
Irving, TX ยท Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... Master's degree (MA/MS) in Psychology, Counseling, Psychiatric Nursing, or Social Work (or ...
Irving, TX ยท Remote
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... Master's degree (MA/MS) in Psychology, Counseling, Psychiatric Nursing, or Social Work (or ...
Dallas, TX ยท On-site +1
Remote ( #LI-Remote ) We are hiring a trial attorney for our Dallas-area staff counsel team! Our ... Consults with the Claims Department on the legal aspects of files and jurisdictional issues.
Dallas, TX ยท On-site +1
Remote ( #LI-Remote ) We are hiring a trial attorney for our Dallas-area staff counsel team! Our ... Consults with the Claims Department on the legal aspects of files and jurisdictional issues.
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... Master's degree (MA/MS) in Psychology, Counseling, Psychiatric Nursing, or Social Work (or ...
Remote/Virtual Hours: Estimated 10-16 hours per month Role: Clinical Specialist About IQVIA IQVIA ... Master's degree (MA/MS) in Psychology, Counseling, Psychiatric Nursing, or Social Work (or ...
Plano, TX ยท Remote
$45 - $65/hr
... trial dates. * Recommend practical next steps and develop action plans to keep civil cases ... Provide day-to-day legal coverage on active files and coordinate closely with attorneys and support ...
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Plano, TX ยท Remote
$45 - $65/hr
... trial dates. * Recommend practical next steps and develop action plans to keep civil cases ... Provide day-to-day legal coverage on active files and coordinate closely with attorneys and support ...
Dallas, TX ยท Remote
$125K - $200K/yr
With a minimum of four years of experience in taking cases from initial filing to trial. Second ... Remote work for candidates not in these locations will be considered for the right candidate. To ...
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Dallas, TX ยท Remote
$125K - $200K/yr
With a minimum of four years of experience in taking cases from initial filing to trial. Second ... Remote work for candidates not in these locations will be considered for the right candidate. To ...
Dallas, TX ยท Remote
$125K - $200K/yr
With a minimum of four years of experience in taking cases from initial filing to trial. Second ... Remote work for candidates not in these locations will be considered for the right candidate. To ...
Quick apply
Dallas, TX ยท Remote
$125K - $200K/yr
With a minimum of four years of experience in taking cases from initial filing to trial. Second ... Remote work for candidates not in these locations will be considered for the right candidate. To ...
Dallas, TX ยท Remote
$58K - $74K/yr
To give clients and files the attention and organization needed to help bring resolution as ... Attend trial * Follow and maintain all firm policies and procedures. * Proportionately contribute ...
Dallas, TX ยท Remote
$58K - $74K/yr
To give clients and files the attention and organization needed to help bring resolution as ... Attend trial * Follow and maintain all firm policies and procedures. * Proportionately contribute ...
Dallas, TX ยท Remote
$58K - $74K/yr
To give clients and files the attention and organization needed to help bring resolution as ... Attend trial * Follow and maintain all firm policies and procedures. * Proportionately contribute ...
Quick apply
Dallas, TX ยท Remote
$58K - $74K/yr
To give clients and files the attention and organization needed to help bring resolution as ... Attend trial * Follow and maintain all firm policies and procedures. * Proportionately contribute ...
Dallas, TX ยท On-site +1
$58K - $74K/yr
To give clients and files the attention and organization needed to help bring resolution as ... Attend trial * Follow and maintain all firm policies and procedures. * Proportionately contribute ...
Dallas, TX ยท On-site +1
$58K - $74K/yr
To give clients and files the attention and organization needed to help bring resolution as ... Attend trial * Follow and maintain all firm policies and procedures. * Proportionately contribute ...
Plano, TX ยท Remote
$101K - $135K/yr
Lead and manage multiple tax engagements, ensuring timely and accurate filings for corporations ... Bachelor's degree in Accounting, Finance, or a related field (Master's in Taxation preferred). 5+ ...
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Plano, TX ยท Remote
$101K - $135K/yr
Lead and manage multiple tax engagements, ensuring timely and accurate filings for corporations ... Bachelor's degree in Accounting, Finance, or a related field (Master's in Taxation preferred). 5+ ...
Fort Worth, TX ยท Remote
$101K - $135K/yr
Lead and manage multiple tax engagements, ensuring timely and accurate filings for corporations ... Bachelor's degree in Accounting, Finance, or a related field (Master's in Taxation preferred). 5+ ...
Quick apply
Fort Worth, TX ยท Remote
$101K - $135K/yr
Lead and manage multiple tax engagements, ensuring timely and accurate filings for corporations ... Bachelor's degree in Accounting, Finance, or a related field (Master's in Taxation preferred). 5+ ...
Dallas, TX ยท Remote
$101K - $135K/yr
Lead and manage multiple tax engagements, ensuring timely and accurate filings for corporations ... Bachelor's degree in Accounting, Finance, or a related field (Master's in Taxation preferred). 5+ ...
Quick apply
Dallas, TX ยท Remote
$101K - $135K/yr
Lead and manage multiple tax engagements, ensuring timely and accurate filings for corporations ... Bachelor's degree in Accounting, Finance, or a related field (Master's in Taxation preferred). 5+ ...
Maintaining our company culture across all regions, and especially with our remote employees, is ... Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health ...
Maintaining our company culture across all regions, and especially with our remote employees, is ... Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health ...
Dallas, TX ยท On-site +1
$54K - $87K/yr
... files upon disposition of cases; and preparing appellate trial documents and exhibits. Education: One full year of graduate level study, or possess a Master's or higher degree, e.g., Ph.D., etc., in ...
Dallas, TX ยท On-site +1
$54K - $87K/yr
... files upon disposition of cases; and preparing appellate trial documents and exhibits. Education: One full year of graduate level study, or possess a Master's or higher degree, e.g., Ph.D., etc., in ...
Fort Worth, TX ยท On-site +1
$54K - $87K/yr
... files upon disposition of cases; and preparing appellate trial documents and exhibits. Education: One full year of graduate level study, or possess a Master's or higher degree, e.g., Ph.D., etc., in ...
Fort Worth, TX ยท On-site +1
$54K - $87K/yr
... files upon disposition of cases; and preparing appellate trial documents and exhibits. Education: One full year of graduate level study, or possess a Master's or higher degree, e.g., Ph.D., etc., in ...
Fort Worth, TX ยท On-site +1
$54K - $87K/yr
... files upon disposition of cases; and preparing appellate trial documents and exhibits. Education: One full year of graduate level study, or possess a Master's or higher degree, e.g., Ph.D., etc., in ...
Fort Worth, TX ยท On-site +1
$54K - $87K/yr
... files upon disposition of cases; and preparing appellate trial documents and exhibits. Education: One full year of graduate level study, or possess a Master's or higher degree, e.g., Ph.D., etc., in ...
$11.65 - $12.69
1% of jobs
$12.69 - $13.73
3% of jobs
$13.73 - $14.76
9% of jobs
$14.76 - $15.80
12% of jobs
$15.83 is the 25th percentile. Wages below this are outliers.
$15.80 - $16.84
21% of jobs
The median wage is $17.06 / hr.
$16.84 - $17.88
20% of jobs
$18.56 is the 75th percentile. Wages above this are outliers.
$17.88 - $18.92
14% of jobs
$18.92 - $19.95
9% of jobs
$19.95 - $20.99
5% of jobs
$20.99 - $22.03
4% of jobs
$22.03 - $23.07
2% of jobs
$11
$17
$23
| Aspect | Remote Trial Master File | Clinical Trial Associate |
|---|---|---|
| Credentials | Typically requires knowledge of GCP, ICH guidelines, and document management | Requires knowledge of clinical trial processes, GCP, and data entry |
| Work Environment | Remote, document management systems, cloud-based platforms | Office or site-based, assisting with trial coordination and data collection |
| Industry Usage | Used across pharmaceutical, biotech, and CROs for document oversight | Commonly employed in clinical research teams for trial support |
The Remote Trial Master File focuses on managing and maintaining essential trial documents remotely, ensuring compliance and accessibility. In contrast, a Clinical Trial Associate supports trial activities on-site or remotely, handling data collection and coordination. Both roles are vital in clinical research but differ mainly in scope and responsibilities.
The most popular types of Trial Master File jobs in Dallas, TX are:
For Remote Trial Master File jobs in Dallas, TX, the most frequently searched job titles are:
The top searched job categories for Remote Trial Master File jobs in Dallas, TX are:
Cities near Dallas, TX with the most Remote Trial Master File job openings:

Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 17 days ago
Location: Remote (U.S.)
Department: Compliance & Data Management
Reports To: SVP, Compliance & Data Management
We are a leading marketing and regulatory research organization specializing in complex, high-quality studies that support business decision-making, public health initiatives, and regulated research programs. Our work combines advanced data collection technologies, rigorous quality standards, and defensible analytics to deliver reliable insights for clients across commercial, healthcare, and regulated sectors.
We are seeking an experienced Regulatory Data Manager (RDM) to lead the planning, implementation, quality control, and governance of regulated research data. This role ensures data integrity, regulatory compliance, audit readiness, and timely delivery of high-quality datasets and supporting documentation throughout the research lifecycle.
#LI-Remote
Position SummaryThe Regulatory Data Manager is responsible for designing, managing, validating, reconciling, and reporting regulated research data from protocol development through database lock and final reporting suitable for client submission to the FDA. The role serves as the primary steward of study data, ensuring that data collection systems, documentation, quality controls, and deliverables meet regulatory, client, and internal quality requirements. This position collaborates closely with project management, field operations, biostatistics, analytics, compliance, and external stakeholders to support accurate, compliant, and submission-ready research execution.
Key ResponsibilitiesData Managementย ย ย ย ย ย ย ย Lead all data management activities across multiple regulated research studies.
ย ย ย ย ย ย ย ย Develop and maintain SOPs, and manage drafting of:
oย ย Data Management Plans (DMPs)
oย ย Data Validation Plans
oย ย CRF/eCRF specifications
oย ย Data Review Plans
oย ย Database Lock Plans
oย ย Data Transfer Specifications
oย ย Any other client required plans and specifications
ย ย ย ย ย ย ย ย Design, review, and validate electronic data capture (EDC) systems and online survey platforms.
ย ย ย ย ย ย ย ย Ensure accurate mapping of protocol requirements into study databases and collection instruments.
ย ย ย ย ย ย ย ย Manage study metadata, coding standards, edit checks, and validation rules.
ย ย ย ย ย ย ย ย Oversee database development, user acceptance testing (UAT), and production deployment, including CRF design, EDC configuration support, validation checks, and comprehensive data documentation.
ย ย ย ย ย ย ย ย Work with clients' electronic trial master file systems to ensure all data management documentation is correctly formatted, uploaded and quality assured.
Data Quality and Complianceย ย ย ย ย ย ย ย Establish and monitor data quality metrics across studies.
ย ย ย ย ย ย ย ย Conduct routine data review, cleaning, query generation, and discrepancy resolution.
ย ย ย ย ย ย ย ย Support risk-based quality management processes and inspection readiness programs.
ย ย ย ย ย ย ย ย Ensure compliance with:
oย ย FDA regulations
oย ย 21 CFR Part 11
oย ย CDISC standards
oย ย HIPAA
oย ย ICH-GCP
oย ย GDPR (where applicable)
oย ย Internal SOPs and quality requirements, including documentation of data accuracy, integrity, security, audit trails, and regulatory compliance throughout the study lifecycle.
ย ย ย ย ย ย ย ย Perform reconciliation of external vendor data including laboratory and other test data, qualitative coding, digital health, and other ancillary datasets, if required.
Database Lock and Reportingย ย ย ย ย ย ย ย Coordinate interim and final database lock and unlock activities.
ย ย ย ย ย ย ย ย Ensure all outstanding queries and reconciliation activities are resolved before lock.
ย ย ย ย ย ย ย ย Produce data listings, metrics, status reports, and quality dashboards.
ย ย ย ย ย ย ย ย Deliver clean, analyzable datasets to biostatistics and analytics teams.
ย ย ย ย ย ย ย ย Support preparation of study reports, technical reports, regulatory submission materials, and audit responses.
Stakeholder Collaborationย ย ย ย ย ย ย ย Serve as lead data management representative on assigned studies.
ย ย ย ย ย ย ย ย Collaborate with:
oย ย Clients and Sponsors
oย ย Project Managers
oย ย Research Directors
oย ย Statisticians
oย ย Data Scientists
oย ย Compliance Teams
ย ย ย ย ย ย ย ย Participate in study design discussions and protocol reviews to ensure data collection feasibility and quality.
ย ย ย ย ย ย ย ย Provide guidance and training on data management processes, system usage, and study documentation expectations while serving as the primary data management contact for assigned studies.
Process Improvement and Innovationย ย ย ย ย ย ย ย Contribute to SOP development and continuous improvement initiatives.
ย ย ย ย ย ย ย ย Evaluate new technologies, automation tools, and AI-enabled data management solutions.
ย ย ย ย ย ย ย ย Support development of standards for decentralized studies, digital data collection, and real-world data integration.
ย ย ย ย ย ย ย ย Promote best practices aligned with SCDM Good Clinical Data Management Practices (GCDMP), and CDISC/TIG.
Requirements
Required Qualificationsย ย ย ย ย ย ย ย Bachelor's or advanced degree in Life Sciences, Health Informatics, Biostatistics, Epidemiology, Public Health, Computer Science, or a related field.
ย ย ย ย ย ย ย ย Minimum 5 years of regulatory data management experience.
ย ย ย ย ย ย ย ย Experience supporting regulated research in nicotine science (preferred), healthcare research, pharmaceutical, biotechnology, medical device, CRO, or FDA-related studies.
ย ย ย ย ย ย ย ย Strong understanding of regulated study processes, data management principles, data quality controls, GCP requirements, data validation, and applicable regulatory frameworks.
ย ย ย ย ย ย ย ย Experience using EDC/eTMF platforms such as Decipher, Medidata Rave, REDCap, Oracle Clinical, Veeva, TrialKit, MEDRIO or similar systems.
ย ย ย ย ย ย ย ย Working knowledge of SQL, SAS, Power BI, and data visualization/reporting tools.
Preferred Qualificationsย ย ย ย ย ย ย ย Experience supporting FDA submissions or pivotal studies, preferably in the nicotine science space.
ย ย ย ย ย ย ย ย Knowledge of CDISC standards including CDASH, SDTM, and ADaM.
ย ย ย ย ย ย ย ย Experience with electronic patient-reported outcomes (ePRO/eCOA).
ย ย ย ย ย ย ย ย Familiarity with real-world evidence (RWE) data sources, electronic health records such as Epic, decentralized clinical trials, and digital endpoints.
ย ย ย ย ย ย ย ย CCDM (Certified Clinical Data Manager) or other relevant regulatory certification.
ย ย ย ย ย ย ย ย Experience managing external vendors and data integrations.
ย ย ย ย ย ย ย ย Knowledge of AI-enabled data review and quality management technologies.
Success FactorsThe ideal candidate:
ย ย ย ย ย ย ย ย Demonstrates meticulous attention to detail.
ย ย ย ย ย ย ย ย Maintains a strong commitment to data integrity.
ย ย ย ย ย ย ย ย Thrives in a highly regulated environment.
ย ย ย ย ย ย ย ย Communicates effectively with both technical and non-technical stakeholders.
ย ย ย ย ย ย ย ย Balances quality, compliance, and operational efficiency.
ย ย ย ย ย ย ย ย Takes ownership of data from study startup through closeout.
Why Join Usย ย ย ย ย ย ย ย Work on high-impact research supporting public health and regulatory decision-making.
ย ย ย ย ย ย ย ย Collaborate with cross-functional experts in research, analytics, and compliance.
ย ย ย ย ย ย ย ย Opportunity to help shape next-generation data governance and AI-enabled research operations.
ย ย ย ย ย ย ย ย Opportunity for professional growth
Benefits
Sourced by ZipRecruiter
Marketing research
201 - 500 Employees
Irving, TX, US
1965