Remote Regulatory Data Manager — Compliance & QA

M/A/R/C Research; Plano (TX); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health care plan

401k with company match

Profit sharing

Paid time off

Family leave

Training & development

Job summary

M/A/R/C Research is seeking an experienced Regulatory Data Manager to lead data management for regulated studies, ensuring data integrity, regulatory compliance, and submission-ready datasets for FDA. You will design, validate, and govern data capture systems, collaborate with cross-functional teams, and drive quality controls across the lifecycle.

You will coordinate with project management, biostatistics, analytics, compliance, and external stakeholders to ensure data management deliverables

Qualifications

• Bachelor’s or advanced degree in Life Sciences, Health Informatics, Biostatistics, Epidemiology, Public Health, CS, or related field.
• Minimum 5 years of regulatory data management experience.
• Experience with regulated research in nicotine science, healthcare research, pharmaceutical, biotechnology, medical device, CRO, or FDA-related studies.
• Strong understanding of regulated study processes, data management principles, data quality controls, GCP requirements, data validation, and applicable regulatory frameworks.
• Experience using EDC/eTMF platforms such as Decipher, Medidata Rave, REDCap, Oracle Clinical, Veeva, TrialKit, MEDRIO or similar systems.

Responsibilities

• Lead all data management activities across multiple regulated research studies.
• Develop and maintain SOPs, and manage drafting of: Data Management Plans (DMPs), Data Validation Plans, CRF/eCRF specifications, Data Review Plans, Database Lock Plans, Data Transfer Specifications, and other client plans.
• Design, review, and validate electronic data capture (EDC) systems and online survey platforms.
• Ensure accurate mapping of protocol requirements into study databases and collection instruments.
• Manage study metadata, coding standards, edit checks, and validation rules.
• Oversee database development, UAT, and production deployment, including CRF design and validation checks.
• Collaborate with clients’ electronic trial master file systems for proper formatting, uploading, and quality assurance of data documentation.

Skills

Regulatory data management

SQL

SAS

Power BI

Data visualization

Education

Bachelor’s or advanced degree in Life Sciences, Health Informatics, Biostatistics, Epidemiology, Public Health, CS, or related field

Tools

Decipher

Medidata Rave

REDCap

Oracle Clinical

Veeva

TrialKit

MEDRIO

Job description

M/A/R/C Research is seeking an experienced Regulatory Data Manager to lead data management for regulated studies, ensuring data integrity, regulatory compliance, and submission-ready datasets for FDA. You will design, validate, and govern data capture systems, collaborate with cross-functional teams, and drive quality controls across the lifecycle.

You will coordinate with project management, biostatistics, analytics, compliance, and external stakeholders to ensure data management deliverables