Senior Regulatory Data Manager, Nicotine Sciences

🔥 2 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $120k - $145k / year

⏰ Full Time

🟠 Senior

📊 Data Scientist

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M/A/R/C Research

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1965

📣 Marketing

💼 Consulting

🤝 B2B

Marketing • Consulting • B2B

M/A/R/C Research is a market research and insights firm that provides a broad set of research solutions — including accelerated and curated approaches, multicultural research, exploration & ideation, and innovation & optimization — to help brands with advertising and brand measurement. The firm serves many sectors listed on its site such as consumer goods, financial services, health & well‑being, retail, media & communications, and technology & apps, positioning itself as a business-facing provider of strategic consumer and market insights.

📋 Description

• 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 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, and Data Transfer Specifications. • 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, including completeness, consistency, discrepancy status, query aging, reconciliation status, and database lock readiness. • Conduct data review, cleaning, query generation, discrepancy resolution, and exception documentation. • Ensure data and documentation support 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. • Reconcile external vendor, qualitative coding, laboratory or test, digital health, and ancillary datasets when included in study scope. • Ensure data accuracy, integrity, security, audit trails, controlled access, and traceable documentation. • Coordinate interim and final database lock and unlock activities. • 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 technical reports, study reports, regulatory submission materials, data transfer packages, and audit responses. • Partner with biostatistics and analytics teams on CDISC-aligned outputs, including CDASH, SDTM, and ADaM. • Serve as lead data management representative for assigned nicotine science studies. • Collaborate with clients, sponsors, project managers, research directors, statisticians, data scientists, compliance teams, field operations, technology teams, and external vendors. • Participate in protocol reviews and study design discussions. • Provide guidance and training on data management processes, system usage, documentation standards, and study-specific requirements. • Communicate data risks, decisions, and status updates to technical and non-technical stakeholders. • Contribute to SOP development, controlled document updates, and continuous improvement initiatives. • Evaluate automation, AI-enabled data review, anomaly detection, and dashboarding opportunities. • Support standards for decentralized data collection, digital endpoints, real-world data, external vendor integrations, and sponsor data transfers. • Promote best practices aligned with SCDM Good Clinical Data Management Practices and CDISC implementation guidance.

🎯 Requirements

• 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: Experience supporting FDA submissions, pivotal studies, TPPI studies, AUS studies, PMSS or other FDA CTP-relevant nicotine and tobacco product research. • Preferred: Knowledge of CDISC standards, including CDASH, SDTM, and ADaM. • Preferred: Experience with ePRO/eCOA, online survey data, consumer research data, qualitative coding data, or mixed-methods study data. • Preferred: CCDM certification or another relevant clinical data management, regulatory, quality, or analytics certification. • Preferred: Experience managing external vendors, data integrations, data transfer specifications, and controlled data handoffs. • Preferred: Familiarity with real-world evidence sources, electronic health records, decentralized studies, digital endpoints, and AI-enabled data review technologies.

🏖️ Benefits

• M/A/R/C® is committed to providing an exceptional work environment and excellent benefits. • Health Care Plan (Medical, Dental, Vision & Supplemental) • Retirement Plan (401k with Company Match) • Profit Sharing • Paid Time Off (Vacation, Sick & Public Holidays) • Family Leave (Maternity, Paternity) • Training & Development

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