Regulatory Data Manager

Regulatory Data Manager Location: Remote (U.S.) Department: Compliance & Data Management Reports To: SVP, Compliance & Data Management About Us We are a leading marketing and regulatory research organization specializing in complex, high-quality studies that support business decision-making, public health initiatives, and regulated research programs. Our work combines advanced data collection technologies, rigorous quality standards, and defensible analytics to deliver reliable insights for clients across commercial, healthcare, and regulated sectors. 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. 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 dat