Senior Manager, Research Data Operations

We are recruiting for a mission-driven Senior Manager Research Data Operations to join our team!

Were with you for lifes journey. At Denver Health purpose isnt just something we believe inits something we live every day for lifes 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 Departments Data Management and Biostatistics functions ensuring these teams operate as a coordinated pipeline in direct support of the departments 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 is an operational and technically literate leadership role with primary technical expertise driven by leads within teams. The Senior Managers 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 the handoff between data management and statistical analysis teams; identifies and resolves bottlenecks that affect project timelines or deliverable a current view of the full project portfolio across both functions; allocates staff resources to meet contractual and internal 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 Departments project needs including REDCap instance management SQL programming data capture systems for surveillance programs and analysis-ready data opportunities to modernize the data workflows specific to the departments active programs. Partners with the departments technical leads and where applicable external vendors to scope and implement system improvements that reduce manual effort or improve data quality for ongoing current on regulatory data standards relevant to the departments deliverables (e.g. 21 CFR Part 11 CDISC FDA data submission expectations as applicable) and ensures the departments systems remain aligned with them. (25%)
• Quality Compliance & Standards Oversight Maintains quality control standards across data management and biostatistics outputs specific to the Research Departments active projects and contractual leadership managing private health data data use agreements secure data transfer de-identification practices and responsible stewardship of sensitive health dataEnsures 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 the Research Departments audit and regulatory review readiness including documentation for systematic literature reviews surveillance programs and registry studies. (20%)
• Staff Development & Team LeadershipDirectly supervises supervisors and staff of the data management and biostatistics teams provides coaching performance management and development a collaborative working relationship between the two teams with shared accountability for project-level outcomes within the Research skill or capacity gaps within the departments data management and biostatistics teams and recommends training tooling or staffing 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 project-level client and sponsor communication on data deliverables timelines and system capabilities when requested by project operational perspective to department-level planning discussions regarding upcoming project load and resourcing needs. (10%)

Education:

• Masters Degree Masters 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 identifies opportunities to improve data systems reduce operational friction and enhance the quality and efficiency of research data workflows.
• Comfortable operating at the intersection of technology science and operations; capable of translating organizational goals into system and process requirements.
• Proactively identifies opportunities to improve data systems reduce operational friction and enhance the quality and efficiency of research data workflows.
• Comfortable operating at the intersection of technology science and operations; capable of translating organizational goals into system and process requirements.
• Keeps pace with developments in health data infrastructure pharmacovigilance data standards and real-world evidence methodology.
• Strong people management skills including performance development coaching conflict resolution and team building across technical disciplines.
• Effective at managing across functions with different technical cultures and priorities.
• Sound judgment in resource allocation priority-setting and cross-functional decision-making.
• Communicates effectively with both technical staff and non-technical stakeholders including clients sponsors and organizational leadership.
• Capable of translating complex data operations into clear project status risk flags and strategic recommendations for leadership audiences.
• Experience participating in client-facing discussions related to data capabilities timelines and deliverables.

Shift

Work Type

Regular

Salary

$109200.00 - $174800.00 / yr

Benefits

At Denver Health we take care of the people who take care of our community. Our benefits are built to support your life your family and your future with generous paid time off fully paid parental leave exceptional retirement contributions comprehensive health coverage and nationally recognized well-being programs. We invest in your growth through tuition assistance career advancement pathways and professional development while also offering meaningful financial advantages through loan forgiveness eligibility and employer contributions. When you join Denver Health youre joining a mission-driven organization that invests in you.

Here is a small list of our benefit programs:

• Paid time off starting at 28 days per year inclusive of vacation personal/sick and 7 Holidays
• 100% paid parental leave up to 6 weeks
• Immediate eligibility for retirement plans with employer contribution up to 9.5%
• Generous medical dental vision plans in addition to employer paid disability and life insurance.
• Comprehensive well-being programs including on-site employee fitness center located on Denver Health main campus and nationally recognized RESTORE Center
• Free RTD EcoPass (public transportation)
• Childcare discount programs & exclusive perks on large brands travel and more
• Tuition reimbursement & assistance
• Education coaching and professional development opportunities through the Workforce Development Center (WFDC) that support internal career growth and advancement pathways
• Professional clinical advancement program & shared governance
• Public Service Loan Forgiveness (PSLF) eligible employer free student loan coaching and assistance navigating the PSLF program
• National Health Service Corps (NHCS) and Colorado Health Service Corps (CHSC) eligible employer

About Denver Health

Denver Health is an integrated high-quality academic healthcare system considered a model for the nation that includes a Level I Trauma Center a 555-bed acute care medical center Denvers 911 emergency medical response system 10 family health centers 19 school-based health centers Rocky Mountain Poison & Drug Safety the Public Health Institute at Denver Health Denver Health Medical Plan and Denver Health Foundation.

As Colorados primary and essential safety-net healthcare system Denver Health is a mission-driven organization that has provided millions in uncompensated care for the uninsured each year.

Located near downtown Denver Denver Health is just minutes away from many of the cultural and recreational activities Denver has to offer.

Denver Health is an equal opportunity employer (EOE). We value the unique ideas talents and contributions reflective of the needs of our community. All job applicants for safety-sensitive positions must pass a pre-employment drug test once a conditional offer of employment has been made. Applicants will be considered until the position is filled.