Regulatory Data Manager

Location: Remote (U.S.)
Department: Compliance & Data Management
Reports To: SVP, Compliance & Data Management

We are seeking an experienced Regulatory Data Manager (RDM) to lead the planning, implementation, quality control, and governance of regulated research data. This role ensures data integrity, regulatory compliance, audit readiness, and timely delivery of high-quality datasets and supporting documentation throughout the research lifecycle.

#LI-Remote

Position Summary

The Regulatory Data Manager is responsible for designing, managing, validating, reconciling, and reporting regulated research data from protocol development through database lock and final reporting suitable for client submission to the FDA. The role serves as the primary steward of study data, ensuring that data collection systems, documentation, quality controls, and deliverables meet regulatory, client, and internal quality requirements. This position collaborates closely with project management, field operations, biostatistics, analytics, compliance, and external stakeholders to support accurate, compliant, and submission-ready research execution.

Key Responsibilities
Data Management
• Lead all data management activities across multiple regulated research studies.
• Develop and maintain SOPs, and manage drafting of:

o Data Management Plans (DMPs)

o Data Validation Plans

o CRF/eCRF specifications

o Data Review Plans

o Database Lock Plans

o Data Transfer Specifications

o Any other client required plans and specifications
• Design, review, and validate electronic data capture (EDC) systems and online survey platforms.
• Ensure accurate mapping of protocol requirements into study databases and collection instruments.
• Manage study metadata, coding standards, edit checks, and validation rules.
• Oversee database development, user acceptance testing (UAT), and production deployment, including CRF design, EDC configuration support, validation checks, and comprehensive data documentation.
• Work with clients' electronic trial master file systems to ensure all data management documentation is correctly formatted, uploaded and quality assured.

Data Quality and Compliance
• Establish and monitor data quality metrics across studies.
• Conduct routine data review, cleaning, query generation, and discrepancy resolution.
• Support risk-based quality management processes and inspection readiness programs.
• Ensure compliance with:

o FDA regulations

o 21 CFR Part 11

o CDISC standards

o HIPAA

o ICH-GCP

o GDPR (where applicable)

o Internal SOPs and quality requirements, including documentation of data accuracy, integrity, security, audit trails, and regulatory compliance throughout the study lifecycle.
• Perform reconciliation of external vendor data including laboratory and other test data, qualitative coding, digital health, and other ancillary datasets, if required.
Database Lock and Reporting
• Coordinate interim and final database lock and unlock activities.
• Ensure all outstanding queries and reconciliation activities are resolved before lock.
• Produce data listings, metrics, status reports, and quality dashboards.
• Deliver clean, analyzable datasets to biostatistics and analytics teams.
• Support preparation of study reports, technical reports, regulatory submission materials, and audit responses.
Stakeholder Collaboration
• Serve as lead data management representative on assigned studies.
• Collaborate with:

o Clients and Sponsors

o Project Managers

o Research Directors

o Statisticians

o Data Scientists

o Compliance Teams
• Participate in study design discussions and protocol reviews to ensure data collection feasibility and quality.
• Provide guidance and training on data management processes, system usage, and study documentation expectations while serving as the primary data management contact for assigned studies.
Process Improvement and Innovation
• Contribute to SOP development and continuous improvement initiatives.
• Evaluate new technologies, automation tools, and AI-enabled data management solutions.
• Support development of standards for decentralized studies, digital data collection, and real-world data integration.
• Promote best practices aligned with SCDM Good Clinical Data Management Practices (GCDMP), and CDISC/TIG.

Requirements
Required Qualifications
• Bachelor's or advanced degree in Life Sciences, Health Informatics, Biostatistics, Epidemiology, Public Health, Computer Science, or a related field.
• Minimum 5 years of regulatory data management experience.
• Experience supporting regulated research in nicotine science (preferred), healthcare research, pharmaceutical, biotechnology, medical device, CRO, or FDA-related studies.
• Strong understanding of regulated study processes, data management principles, data quality controls, GCP requirements, data validation, and applicable regulatory frameworks.
• Experience using EDC/eTMF 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/reporting tools.

Preferred Qualifications
• Experience supporting FDA submissions or pivotal studies, preferably in the nicotine science space.
• Knowledge of CDISC standards including CDASH, SDTM, and ADaM.
• Experience with electronic patient-reported outcomes (ePRO/eCOA).
• Familiarity with real-world evidence (RWE) data sources, electronic health records such as Epic, decentralized clinical trials, and digital endpoints.
• CCDM® (Certified Clinical Data Manager) or other relevant regulatory certification.
• Experience managing external vendors and data integrations.
• Knowledge of AI-enabled data review and quality management technologies.

Success Factors

The ideal candidate:
• Demonstrates meticulous attention to detail.
• Maintains a strong commitment to data integrity.
• Thrives in a highly regulated environment.
• Communicates effectively with both technical and non-technical stakeholders.
• Balances quality, compliance, and operational efficiency.
• Takes ownership of data from study startup through closeout.

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