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.

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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 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 to confirm feasibility data quality expectations and downstream reporting requirements.
• Provide clear guidance and training on data management processes system usage documentation standards and study-specific requirements.
• Communicate data risks decisions and status updates in a concise business-appropriate manner for technical and non-technical stakeholders.

• Contribute to SOP development controlled document updates and continuous improvement initiatives for regulated research data management.
• Evaluate automation AI-enabled data review anomaly detection and dashboarding opportunities that improve quality consistency and efficiency while maintaining appropriate oversight.
• 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.

• Bachelors 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.

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

• Data integrity mindset: Maintains meticulous attention to accuracy completeness traceability and documentation.
• Regulatory discipline: Understands that study data must be defensible inspection-ready and suitable for client regulatory use.
• Nicotine science focus: Applies data management rigor to tobacco and nicotine research questions including perception intention behavior and actual use outcomes.
• Cross-functional communication: Explains data issues risks and decisions clearly to technical and non-technical audiences.
• Operational ownership: Drives data management activities from study startup through closeout database lock and final deliverable transfer.
• Continuous improvement: Identifies ways to improve quality efficiency consistency and automation while preserving human oversight and compliance.

• 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

Required Experience:

Manager