Senior Regulatory Data Manager, Nicotine Sciences

Senior Regulatory Data Manager, Nicotine Sciences

M/A/R/C Research delivers high-quality marketing, public health, and regulatory research for clients operating in complex and highly regulated categories. Our teams combine rigorous study design, advanced data collection technologies, defensible analytics, and strong quality controls to produce reliable, audit-ready evidence.

#LI-Remote

The Senior Regulatory Data Manager, Nicotine Sciences, leads the planning, implementation, validation, quality review, and delivery of regulated study data for nicotine and tobacco product research. This role supports Tobacco Product Perception and Intention (TPPI) studies, Actual Use Studies (AUS), Post marketing Surveillance Studies (PMSS), and other related FDA Center for Tobacco Products (CTP) research programs. The position serves as the primary steward of study data from protocol review through database lock, final reporting, and client-ready regulatory deliverables.

The role requires strong regulatory data management discipline, a practical understanding of survey and electronic data capture environments, and the ability to translate protocol requirements into controlled data collection, review, transfer, and reporting processes. The ideal candidate can work across project management, research, compliance, biostatistics, analytics, field operations, clients, sponsors, and external vendors while maintaining data integrity, inspection readiness, and operational efficiency.

• 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.

• Serve as the lead data management representative for assigned…