Senior Manager, Research Data Operations

About this role

We are recruiting for a mission-driven Senior Manager, Research Data Operations to join our team! We're with you for life’s journey. At Denver Health, purpose isn’t just something we believe in—it’s something we live every day, for life’s journey.

Our Values Respect | Belonging | Accountability | Transparency

Department RMPDS Consulting

Job Summary

The Senior Manager, Research Data Operations provides unified operational leadership over the Research Department's Data Management and Biostatistics functions, ensuring these teams operate as a coordinated pipeline in direct support of the department's research project portfolio. This includes surveillance programs (including the RADARS System), patient registries, statistical analysis plans, and real-world evidence deliverables for regulatory and pharmaceutical clients. This is an operational and technically literate leadership role, with primary technical expertise driven by leads within teams. The Senior Manager's value is in coordinating project workflow between the two functions, maintaining quality and resourcing across the research portfolio, and driving innovation in the data systems and infrastructure the Research Department relies on to deliver its work.

Essential Functions : • Cross-Functional Operations Leadership • Provides unified operational oversight of the Data Management and Biostatistics teams, ensuring coordinated workflow and prioritization across both functions. • Owns the handoff between data management and statistical analysis teams; identifies and resolves bottlenecks that affect project timelines or deliverable quality. • Maintains a current view of the full project portfolio across both functions; allocates staff resources to meet contractual and internal deadlines. • Serves as a single point of operational accountability for integrated data/analysis deliverables requiring both functions. (30%)

• Data Systems Innovation • Leads evaluation and adoption of data systems, processes, and tools that directly support the Research Department’s project needs — including REDCap instance management, SQL programming, data capture systems for surveillance programs, and analysis-ready data pipelines. • Identifies opportunities to modernize the data workflows specific to the department’s active programs. • Partners with the department’s technical leads and, where applicable, external vendors to scope and implement system improvements that reduce manual effort or improve data quality for ongoing studies. • Stays current on regulatory data standards relevant to the department’s deliverables (e.g., 21 CFR Part 11, CDISC, FDA data submission expectations as applicable) and ensures the department’s systems remain aligned with them. (25%)

• Quality, Compliance & Standards Oversight • Maintains quality control standards across data management and biostatistics outputs specific to the Research Department’s active projects and contractual obligations. • Provide leadership managing private health data, data use agreements, secure data transfer, de-identification practices, and responsible stewardship of sensitive health data • Ensures SOPs, documentation practices, and data governance are appropriate and consistently applied across both functions for all department deliverables, including FDA-contracted work and sponsor-funded studies. • Supports the Research Department’s audit and regulatory review readiness, including documentation for systematic literature reviews, surveillance programs, and registry studies. (20%)

• Staff Development & Team Leadership • Directly supervises supervisors and staff of the data management and biostatistics teams provides coaching, performance management, and development planning. • Builds a collaborative working relationship between the two teams, with shared accountability for project-level outcomes within the Research Department. • Identifies skill or capacity gaps within the department’s data management and biostatistics teams and recommends training, tooling, or staffing solutions. • Oversees staff assignment processes and effort allocation. (15%)

• Strategic Contribution & Client Engagement • Provides input to Research Department leadership on data, analytics, and technical capacity when scoping new projects or proposals. • Supports project-level client and sponsor communication on data deliverables, timelines, and system capabilities when requested by project leads. • Contributes operational perspective to department-level planning discussions regarding upcoming project load and resourcing needs. (10%)

Education : • Master's Degree Master’s degree required in a relevant field (e.g., Health Informatics, Biostatistics, Epidemiology, Computer Science, Public Health, or related discipline)

Work Experience : • 7-9 years Progressive experience in research data management, biostatistics operations, health informatics, or a related field. Required and

• 4-6 years Experience managing or leading multidisciplinary teams in a research, pharmaceutical, CRO, or regulatory science environment Required and

• 1-3 years Demonstrated experience leading or contributing to data system evaluation, implementation, or modernization efforts Required and

• 4-6 years Experience working within or adjacent to regulated research environments (e.g., FDA, IRB, GCP, or 21 CFR Part 11 contexts) preferred Required and

Licenses :

Knowledge, Skills and Abilities : • Sufficient understanding of relational databases, SQL environments, tableau, and statistical programming (SAS/R) to evaluate technical work, ask informed questions, and assess system requirements — without serving as a hands-on technical lead. • Familiarity with research data platforms including REDCap and electronic data capture systems. • Ability to evaluate data infrastructure proposals, vendor solutions, and technology options in the context of organizational needs and regulatory requirements. • Proactively identifie

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