This position is incentive eligible.

The Manager of Records-Based Research plays a pivotal role in driving research in the healthcare setting as a leader in the HCA Healthcare Research Institute's Advanced Records-Based Outcomes Research (ARBOR) team. This manager role combines observational research proficiency, leadership skills, and business insight to lead multidisciplinary teams in delivering high quality and robust research products.

The Manager of Records-Based Research is responsible for the planning, preparation, management, leadership, analysis, and delivery of a broad portfolio of outcomes research studies. The Manager of Records-Based Research has a critical role in contributing to the growth of research programs and initiatives across HCA Healthcare by supporting the Research Institute program development team as they build a research portfolio aligned with service line leadership and our national physician leaders across the following service lines and lines of business: neuroscience, cardiac and vascular, women's and children's, oncology, early detection, infectious disease, spine, orthopedics, pulmonary and thoracic, robotics, behavioral health, quality and safety, graduate medical education, burn, bariatrics, trauma, and nurse navigation.

Under the guidance of the Director, the Manager of Records-Based Research is responsible for overseeing observational research projects, training and guiding teams of research scientists and outcomes investigators, and ensuring that business objectives are met through effective, rigorous, and compliant research practices. Importantly, this position models best research practices, supports the development of processes to build a scalable and sustainable research program, acts as both mentor and people leader to a team of high-performers, and is expected to seek out knowledge of existing and emerging data science principles, theories, and techniques to inform research designs, business decisions, and technology integrations.

This position serves as an educator and expert resource for end-to-end research. As such, the Manager of Records-Based Research not only leads a team of outcome investigators but also collaborates with and supports colleagues in program development and strategy, business development, project and program management, data science and informatics, business intelligence, budgets and finance, accounting, contracting and legal, ethics and compliance, regulatory, clinical operations, information technology, research operations, research education, and site management operations. This position also engages external stakeholders including academic partners, non-profits, sponsors, contract research organizations (CROs), and vendors. Opportunities abound but challenges faced are difficult and often complex, requiring frequent communication and interaction with leadership.

In summary, this is a highly visible and regarded role at HCA Healthcare that supports the growth and visibility of an observational enterprise-wide research portfolio. The goal is to improve the quality of care and the lives of all patients through evidence-based practice. This research pipeline spans real-world evidence (RWE), epidemiology, translational research, quality improvement, health equity, patient reported outcomes (PROs), post-market safety, and implementation science and has the opportunity to directly impact patient care and outcomes in one of the largest healthcare systems in the United States.

LOCATION: This position is Work from Home but requires the ability to travel to corporate offices in Nashville, Tennessee for critical stakeholder meetings 1-2 days per month. Local is preferred.

SUPERVISOR: Director, Records-Based Research

SUPERVISES: Investigator, HEOR or Outcomes Investigators

DUTIES INCLUDE BUT NOT LIMITED TO:

• Lead, train, mentor and manage a team of outcome investigators, fostering collaboration and skill development under the guidance of the Director
• Maintain transparency and alignment with the Director of Records-Based Research to support a sustainable observational research program
• Collaborate with Director and senior leadership on business cases and strategic planning
• Work interactively with all functional units/support teams of HCA Healthcare to help achieve the company's mission and vision
• Support business development and program strategy teams in fostering strategic internal and external partnerships in order to grow the observational research portfolio
• Develop new opportunities, execute studies, and achieve high quality deliverables to meet business goals
• Collaborate with physicians, clinical thought leaders, and sponsors in the design and execution of research in alignment with both HCA Healthcare Research Institute and Service Line strategic goals
• Develop and maintain excellent relationships with research and data-related personnel, HCA research and IT colleagues, Research Institute management, physicians, and ancillary departments
• Collaborate with multi-disciplinary teams and cross-functional colleagues to implement and evolve research operations services, research processes, data system architecture, and data integrations
• Lead and support research pipeline activities through concept ideation, sponsor engagement, physician engagement, data feasibility, operational feasibility, timeline development, budget development, and proposal development
• Develop, implement, and oversee advanced statistical modeling and quantitative statistics
• Ensure data quality, integrity, and security while maintaining compliance with applicable regulations and policies
• Develop and enforce standard operating procedures (SOPs) for the study team including training documents, templates, tools, documentation requirements, etc.
• Develop and promote research processes that ensure strategic alignment and efficient resource utilization across HCA Healthcare Service Lines as well as across HCA Healthcare support teams
• Lead and support study startup activities through study design, protocol development, statistical analysis plan development, data management plan development, and informed consent form (ICF) development
• Lead and support study execution by overseeing data science team activities, reviewing of data dictionaries and data sources, ensuring proper implementation of the protocol and statistical analysis plan, critically reviewing results and data science reports, addressing confounding and biases, and identifying study design and data limitations when interpreting results
• Provide effective leadership and creative thinking in resolving problems and removing study barriers as needed
• Lead and support study results reporting by providing critical data review, interpreting and discussing scientific results, conveying complex statistical methodology to a broad audience, writing and reviewing study abstracts, developing and reviewing posters, writing and reviewing white papers, writing and reviewing manuscripts, developing and reviewing marketing materials, and preparing and reviewing presentations
• Lead study teams meetings and sponsor engagements with confidence and ease
• Oversee the resolution of complex issues related to measurement methodologies, study design and advanced statistical analyses
• Maintain a high degree of awareness of the current scientific state and advances in relation to the clinical research portfolio you support by attendance at relevant symposia, scientific meetings and workshops as well as review of key literature
• Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement" as well as serve as a compass for research ethics, compliance, and upholding confidentiality
• Complete training assignments and standard operating procedures (SOPs) reviews by the due dates
• Track and communicate with direct reports to ensure their completion of training assignments and standard operating procedures (SOPs) reviews by the due dates
• Maintain organized and detailed records and documents in an approved shared drive, Sharepoint, and/or eBinder according to defined processes and SOPs
• Attend internal and external study team meetings, weekly departmental meetings, ancillary department meetings, and applicable leadership meetings
• Support Outcome Investigators through peer-review of study design and written documents as well as support the Pubclear process as trained reviewer
• Assist with onboarding new data-focused team members, training on department policies, procedures and workflows as needed
• Support the data science team in developing and optimizing data collection systems and processes, including big data pipelines
• Communicate complex data findings to both technical and non-technical stakeholders effectively
• Manage project timelines, time tracking, budgets and resource allocation for assigned studies
• Knowledge in domain modeling and relational database design, data transfer methods, electronic health record and healthcare claims standards and/or analytical techniques used in research programs
• Stay up to date with industry trends, AI/ML techniques, and emerging data technologies
• Develop study designs and analytic solutions based on available data sources, stakeholder needs, and timelines

EDUCATION:

• Doctorate's degree in Epidemiology, Biological Sciences, Population Sciences, Public Health, or Equivalents (PhD, MD, DPH, DMSc, or PharmD) is required.

EXPERIENCE (Required):

• 10+ years of post-doctoral experience in one or more of the following:
• Education/Academia
• Industry (drug or device)
• Healthcare Research
• Contract Research Organization (CRO)
• Research Startup
• 2+ years of experience managing a team or in a leadership role
• 4+ years of experience in healthcare and/or clinical research environments
• 2+ years of experience with supporting pharma or industry funded research
• 2+ years of experience in one or more of the following types of research: RWE, HEOR, clinical quality and safety, biomarker, translational, population sciences, public health, epidemiology, or observational research equivalents
• 6+ manuscripts published as a significant contributor and author
• Knowledge of Good Clinical Practice, HIPAA, DHHS 45 CFR 46, and FDA 21 CFR regulations

EXPERIENCE (Preferred):

• 5+ years of experience within the HCA Healthcare network or equivalent large healthcare system
• 2+ years working with or supporting CRO functionality including study design, protocol development, SAP/DMP documentation, working with electronic data capture (EDC) systems, eCRF creation, writing ICFs etc.
• Any experience in survey design or ePROs
• Any experience working with big-data and research registry development

Benefits

HCA Healthcare offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:

• Comprehensive benefits for medical, prescription drug, dental, vision, behavioral health and telemedicine services
• Wellbeing support, including free counseling and referral services
• Time away from work programs for paid time off, paid family leave, long- and short-term disability coverage and leaves of absence
• Savings and retirement resources, including a 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service), Employee Stock Purchase Plan, flexible spending accounts, preferred banking partnerships, retirement readiness tools, rollover support and financial wellbeing counseling
• Education support through tuition assistance, student loan assistance, certification support, dependent scholarships and a partnership with Galen College of Nursing
• Additional benefits for fertility and family building, adoption assistance, life insurance, supplemental health protection plans, auto and home insurance, legal counseling, identity theft protection and consumer discounts

Learn more about Employee Benefits

Note: Eligibility for benefits may vary by location.

If you find this opportunity compelling, we encourage you to apply for our Manager of Records Based Research WFH opening. We promptly review all applications. Highly qualified candidates will be directly contacted by a member of our team. We are interviewing - apply today!