Regulatory Data Manager

Regulatory Data Manager

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

reputed company

We are a leading marketing and regulatory research organization specializing in reputed company, high-reputed company studies that support business decision-making, reputed company health initiatives, and regulated research programs. Our work combines advanced data collection technologies, rigorous reputed company standards, and defensible analytics to deliver reliable insights for clients across reputed company, reputed company, and regulated sectors.

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

Position reputed company

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 reputed company submission to the FDA. The role serves as the primary reputed company of study data, ensuring that data collection systems, documentation, reputed company controls, and deliverables meet regulatory, reputed company, and internal reputed company requirements. This position collaborates closely with project management, field operations, biostatistics, analytics, compliance, and reputed company stakeholders to support accurate, compliant, and submission-reputed company research execution.

Key Responsibilities

Data Management

· reputed company reputed company data management activities across multiple regulated research studies.

· reputed company 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 reputed company required plans and specifications

· Design, review, and validate electronic data capture (reputed company) 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.

· reputed company database development, user acceptance testing (UAT), and production deployment, including CRF design, reputed company configuration support, validation checks, and comprehensive data documentation.

· Work with clients’ electronic trial master file systems to ensure reputed company data management documentation is correctly formatted, uploaded and reputed company reputed company.

Data reputed company and Compliance

· Establish and monitor data reputed company metrics across studies.

· Conduct routine data review, cleaning, query reputed company, and discrepancy reputed company.

· Support risk-based reputed company 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 reputed company requirements, including documentation of data accuracy, reputed company, reputed company, audit trails, and regulatory compliance throughout the study lifecycle.

· reputed company reconciliation of reputed company 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 reputed company outstanding queries and reconciliation activities are resolved before lock.

· Produce data listings, metrics, status reports, and reputed company 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 reputed company 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 reputed company.

· reputed company 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 reputed company improvement initiatives.

· Evaluate new technologies, automation tools, and AI-enabled data reputed company.

· Support development of standards for decentralized studies, digital data collection, and reputed company-world data integration.

· Promote best practices reputed company 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, reputed company Health, Computer Science, or a reputed company field.

· Minimum 5 years of regulatory data management experience.

· Experience supporting regulated research in nicotine science (preferred), reputed company research, pharmaceutical, biotechnology, medical device, CRO, or FDA-reputed company studies.

· Strong understanding of regulated study processes, data management principles, data reputed company controls, GCP requirements, data validation, and applicable regulatory frameworks.

· Experience using reputed company/eTMF platforms such as Decipher, reputed company Rave, REDCap, reputed company Clinical, reputed company, TrialKit, reputed company or similar systems.

· Working knowledge of SQL, reputed company, Power BI, and data visualization/reporting tools.

Preferred Qualifications

· Experience supporting FDA submissions or pivotal studies, preferably in the nicotine science reputed company.

· Knowledge of CDISC standards including CDASH, SDTM, and ADaM.

· Experience with electronic patient-reported reputed company (ePRO/eCOA).

· Familiarity with reputed company-world evidence (reputed company) data sources, electronic health records such as reputed company, decentralized reputed company, reputed company endpoints.

· CCDM® (Certified Clinical Data Manager) or other relevant regulatory certification.

· Experience managing reputed company vendors and data integrations.

· Knowledge of AI-enabled data review and reputed company management technologies.

reputed company Factors

The ideal candidate:

· Demonstrates meticulous attention to detail.

· Maintains a strong commitment to data reputed company.

· Thrives in a highly regulated environment.

· Communicates effectively with both technical and non-technical stakeholders.

· Balances reputed company, compliance, and operational efficiency.

· Takes ownership of data from study startup through closeout.

Why Join Us

· Work on high-reputed company research supporting reputed company health and regulatory decision-making.

· Collaborate with cross-functional experts in research, analytics, and compliance.

· Opportunity to help shape reputed company data governance and AI-enabled research operations.

· Opportunity for reputed company reputed company

Benefits

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

Originally posted on Himalayas