Remote Senior Regulatory Data Manager - Nicotine Sciences

M/A/R/C Research, LLC; Plano (TX); Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental, Vis

Retirement Plan (401k with Company M

Profit Sharing

Paid Time Off (Vacation, Sick & Public

Family Leave (Maternity, Paternity)

Training & Development

Job summary

M/A/R/C Research in Plano, TX, seeks a Senior Regulatory Data Manager, Nicotine Sciences, to lead data management for regulated nicotine studies, coordinate data capture, validation, and reporting from protocol to regulatory deliverables.

You will ensure compliance with FDA/CTP expectations, CDISC standards, and data integrity across TPPI, AUS, PMSS programs, collaborating with sponsors, biostatistics, and vendors.

Qualifications

• Bachelor's or advanced degree in Life Sciences, Health Informatics, Biostatistics, Epidemiology, Public Health, Computer Science, Data Science, or a related field.
• At least 5 years of clinical, regulatory, or research data management experience in a regulatory environment.
• Experience supporting nicotine science, tobacco product research, public health research, healthcare research, pharmaceutical research, biotechnology, medical device, CRO, or FDA-related studies.
• Strong understanding of regulated study processes, data management principles, data validation, data quality controls, audit readiness, and applicable regulatory frameworks.
• Hands-on experience with EDC, eTMF, survey, or clinical data platforms such as Decipher, Medidata Rave, REDCap, Oracle Clinical, Veeva, TrialKit, MEDRIO, or similar systems.
• Working knowledge of SQL, SAS, Power BI, and data visualization or reporting tools.
• Ability to create clear data management documentation, quality reports, issue logs, decision records, and sponsor-facing deliverables.
• Strong analytical, organizational, communication, and problem-solving skills.

Responsibilities

• Lead data management activities for regulated nicotine science studies, including TPPI, AUS, PMSS, consumer perception, intention, behavioral, and related public health research programs.
• Translate protocols, statistical analysis plans, survey instruments, and client specifications into clear data management requirements.
• Develop and maintain study-specific data management documentation, including Data Management Plans, Data Validation Plans, CRF/eCRF specifications, Data Review Plans, Database Lock Plans, Data Transfer Specifications, and related client-required plans.
• Design, review, validate, and support electronic data capture systems, online survey platforms, ePRO/eCOA tools, and other study data collection environments.
• Manage study metadata, codebooks, coding standards, edit checks, validation rules, derivation logic, and controlled data specifications.
• Oversee database build, configuration support, user acceptance testing, production deployment, and version-controlled documentation.
• Establish and monitor data quality metrics across assigned studies, including completeness, consistency, discrepancy status, query aging, reconciliation status, and database lock readiness.
• Conduct routine data review, cleaning, query generation, discrepancy resolution, and exception documentation.
• Ensure study data and documentation support applicable regulatory, client, and internal quality requirements, including FDA expectations, 21 CFR Part 11, ICH-GCP where applicable, HIPAA, GDPR where applicable, CDISC standards, and internal SOPs.
• Support risk-based quality management, audit readiness, and inspection response activities.
• Perform or oversee reconciliation of external vendor data, qualitative coding, laboratory or test data, digital health data, and other ancillary datasets when included in the study scope.
• Ensure data accuracy, integrity, security, audit trails, controlled access, and traceable documentation throughout the study lifecycle.
• Coordinate interim and final database lock and unlock activities, ensuring queries, reconciliation items, and quality exceptions are resolved or documented before lock.
• Produce data listings, status reports, data quality dashboards, and study-level data management metrics.
• Deliver clean, analyzable datasets and supporting documentation to biostatistics, analytics, clients, sponsors, and regulatory teams.
• Support preparation of technical reports, study reports, regulatory submission materials, data transfer packages, and audit responses.
• Partner with biostatistics and analytics teams to support CDISC-aligned outputs, including CDASH, SDTM, and ADaM where required by the study.

Skills

Analytical

Organizational

Communication

Problem-solving

Education

Bachelor's or advanced degree in Life Sciences/Health Informatics/Biostatistics

CCDM certification or similar

Tools

Decipher

Medidata Rave

REDCap

Oracle Clinical

Veeva

TrialKit

MEDRIO

Job description

M/A/R/C Research in Plano, TX, seeks a Senior Regulatory Data Manager, Nicotine Sciences, to lead data management for regulated nicotine studies, coordinate data capture, validation, and reporting from protocol to regulatory deliverables.

You will ensure compliance with FDA/CTP expectations, CDISC standards, and data integrity across TPPI, AUS, PMSS programs, collaborating with sponsors, biostatistics, and vendors.