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Research Regulatory Manager

Optum
401(k)
United States, Minnesota, Eden Prairie
11000 Optum Circle (Show on map)
Oct 14, 2025

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together.

In support of the quadruple aim and Optum Care's mission, the Center for Research and Innovation (OCRI) Regulatory Manager will work integrally with the research teams and serves as the regulatory subject-matter resource. The Manager will report to the OCRI Executive Director and acts as a liaison between OCRI, industry sponsors and the various research sites and IRBs that Optum Care partners with, secures IRB approval for new research studies, and ensures effective and timely reporting and exchange of regulatory correspondence and metrics related to the multitude of research studies performed by our Care Delivery Organizations (CDOs). Dependent upon interest, experience, and need, the Specialist may also have growth/development opportunities such as oversight of additional research staff, quality monitoring or contributing to research education and training.

Primary Responsibilities:

  • Serves as an independent expert resource to research study staff and investigators in the interpretation and application of IRB requirements, the Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
  • Provides regulatory oversight and assistance to the research teams by collecting, preparing, editing and study related documents which may include: IRB applications, consent forms, reports and correspondence for Enterprise level projects
  • Implements, updates and maintains CTMS system and oversee research sites with essential documentation on all studies under OCRI's purview
  • Communicates regularly with research study staff, sponsors, IRBs and other stakeholders regarding the status of startup and ongoing regulatory duties
  • Works collaboratively with OCRI leadership and employees as part of a positive, supportive culture
  • Provides Leadership with routine metrics, analysis and reporting related to regulatory and compliance functions and works collaboratively on potential solutions to address concerns or areas of potential risk
  • Leads efforts to assess potential expansion of regulatory staff role and assists in development, change management around and implementation of any expansion
  • Scans, evaluates and translate for implementation changes in applicable laws, regulations, guidance, Federal agency expectations and national practice standards
  • Creates and improves upon SOPs, guidelines, tools, and processes to support high-quality IRB and regulatory work and general research compliance
  • Develops and executes a regulatory monitoring and auditing process to ensure compliance with applicable internal, federal and state regulations
  • Delivers routine educational and training content to research staff on an as-needed basis
  • With Program Manager, develops and implements robust, multi-faceted internal quality monitoring program, to include creation of tools, strategic plan and routine metrics and reporting
  • Other opportunities for significant, high-level contribution may be available dependent upon candidate interest and experience and program need

You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

  • 3+ years of experience in clinical research with a deep understanding of regulatory document requirements
  • Proven working knowledge of applicable FDA, IRB and HIPAA regulations and guidance, ICH GCP standards, etc.
  • Ability to think critically, exercise sound independent judgment, adapt to an evolving internal and external regulatory environment, and manage competing priorities
  • Ability to recognize problems or situations that are new or do not have clear precedent; evaluates alternatives and finds solutions that fall within applicable policies and regulations
  • Proven solid interpersonal and influence skills with the ability to work with others as a team and in support of a positive work culture across enterprise and cross-functional
  • Driver's License and access to reliable transportation

Preferred Qualifications:

  • Certification in clinical research, IRB, or healthcare compliance (including but not limited to CCRA, CCRC, ACRP-CP, or CIP)
  • Experience auditing or monitoring research

Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $89,900 to $160,600 annually based on full-time employment. We comply with all minimum wage laws as applicable.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.

UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

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