Senior Regulatory Data Manager - Nicotine Science Studies

M/A/R/C Research; Plano (TX); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental, V&D

401k with Company Match

Profit Sharing

Paid Time Off

Family Leave

Training & Development

Job summary

At M/A/R/C Research in Plano, TX, the Senior Regulatory Data Manager, Nicotine Sciences, leads planning, implementation, validation, quality review, and delivery of regulated study data for TPPI studies, AUS, PMSS, and related FDA CTP programs. This role ensures data integrity, audit readiness, and compliant reporting across stakeholders.

The role requires strong regulatory data management discipline and hands-on experience with EDC/ePRO, survey platforms, and CDISC standards, working across

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
• Preferred: FDA submission experience, CDISC standards familiarity, ePRO/eCOA experience, CCDM certification

Responsibilities

• Lead data management activities for regulated nicotine science studies (TPPI, AUS, PMSS, etc.)
• Translate protocols, analysis plans, survey instruments into data management requirements
• Develop and maintain study data management documentation (DM Plans, Validation Plans, CRF/eCRF specs)
• Design, validate, and support EDC systems and online survey platforms
• Manage study metadata, coding standards, edit checks, validation rules, and data derivation
• Oversee database build, testing, deployment, and documentation
• Establish and monitor data quality metrics and ensure audit readiness
• Coordinate interim/final database locks and deliverables to stakeholders
• Produce data listings, quality dashboards, and study-level metrics
• Support regulatory submissions, data transfers, and CDISC-aligned outputs
• Collaborate with biostatistics, analytics, clients, sponsors, and vendors
• Provide guidance and training on data management processes and standards
• Promote continuous improvement in data management and automation

Skills

Analytical skills

Organizational skills

Communication skills

Problem-solving skills

Regulatory discipline

Data integrity mindset

Education

Bachelor's degree or higher in Life Sciences/Health Informatics/Biostatistics/Epidemiology/Public Health/CS/Data Science

Tools

EDC systems (Decipher, Medidata Rave, REDCap)

eTMF platforms

SAS

SQL

Power BI

CDISC (CDASH/SDTM/ADaM)

Oracle Clinical

Veeva

TrialKit

MEDRIO

Job description

At M/A/R/C Research in Plano, TX, the Senior Regulatory Data Manager, Nicotine Sciences, leads planning, implementation, validation, quality review, and delivery of regulated study data for TPPI studies, AUS, PMSS, and related FDA CTP programs. This role ensures data integrity, audit readiness, and compliant reporting across stakeholders.

The role requires strong regulatory data management discipline and hands-on experience with EDC/ePRO, survey platforms, and CDISC standards, working across