Senior Regulatory Data Manager, Nicotine Sciences

This is a fully remote position, open to applicants in Texas.

📋 Description

• Lead data management initiatives for regulated nicotine science studies, encompassing TPPI, AUS, PMSS, consumer perception, intention, behavioral, and related public health research programs.

• Convert protocols, statistical analysis plans, survey instruments, and client specifications into data management requirements.

• Create 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, evaluate, validate, and support electronic data capture systems, online survey platforms, ePRO/eCOA tools, and other environments for data collection in studies.

• Oversee study metadata, codebooks, coding standards, edit checks, validation rules, derivation logic, and controlled data specifications.

• Manage database construction, configuration support, user acceptance testing, production deployment, and version-controlled documentation.

• Establish and track data quality metrics, covering completeness, consistency, discrepancy status, query aging, reconciliation status, and database lock readiness.

• Perform data review, cleaning, query generation, discrepancy resolution, and exception documentation.

• Ensure data and documentation comply with FDA expectations, 21 CFR Part 11, ICH-GCP when applicable, HIPAA, GDPR when relevant, CDISC standards, and internal SOPs.

• Assist in risk-based quality management, audit preparedness, and responses to inspections.

• Reconcile external vendor data, qualitative coding, laboratory or test data, digital health, and ancillary datasets included in the study scope.

• Guarantee data accuracy, integrity, security, audit trails, controlled access, and traceable documentation.

• Coordinate interim and final database locking and unlocking activities.

• Generate data listings, status reports, data quality dashboards, and study-level data management metrics.

• Provide clean, analyzable datasets along with supporting documentation to biostatistics, analytics, clients, sponsors, and regulatory teams.

• Aid in the creation of technical reports, study reports, regulatory submission materials, data transfer packages, and responses to audits.

• Collaborate with biostatistics and analytics teams on CDISC-compliant outputs, including CDASH, SDTM, and ADaM.

• Act as the primary data management representative for assigned nicotine science studies.

• Work together with clients, sponsors, project managers, research directors, statisticians, data scientists, compliance teams, field operations, technology teams, and external vendors.

• Engage in protocol reviews and discussions regarding study design.

• Offer guidance and training on data management processes, system usage, documentation standards, and study-specific requirements.

• Communicate data risks, decisions, and status updates to both technical and non-technical stakeholders.

• Contribute to the development of SOPs, updates to controlled documents, and initiatives for continuous improvement.

• Assess opportunities for automation, AI-driven data review, anomaly detection, and dashboarding.

• Support standards for decentralized data collection, digital endpoints, real-world data, external vendor integrations, and sponsor data transfers.

• Advocate for best practices that align 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 discipline.

• Minimum of 5 years of experience in clinical, regulatory, or research data management within a regulated environment.

• Background in supporting nicotine science, tobacco product research, public health research, healthcare research, pharmaceutical research, biotechnology, medical device, CRO, or FDA-related studies.

• In-depth understanding of regulated study processes, data management principles, data validation, data quality controls, audit readiness, and relevant regulatory frameworks.

• Practical experience with EDC, eTMF, survey, or clinical data platforms such as Decipher, Medidata Rave, REDCap, Oracle Clinical, Veeva, TrialKit, MEDRIO, or similar systems.

• Proficient in SQL, SAS, Power BI, and data visualization or reporting tools.

• Capability to produce clear data management documentation, quality reports, issue logs, decision records, and sponsor-facing deliverables.

• Strong analytical, organizational, communication, and problem-solving abilities.

• Preferred: Experience with FDA submissions, pivotal studies, TPPI studies, AUS studies, PMSS, or other FDA CTP-related nicotine and tobacco product research.

• Preferred: Familiarity with 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: Knowledge of real-world evidence sources, electronic health records, decentralized studies, digital endpoints, and AI-driven data review technologies.

🏝️ Benefits

• M/A/R/C® is dedicated to providing an outstanding work environment and exceptional 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