Hartford, CT, US
2 days ago
Lead Director, Research Integrity

Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we deliver our services is just as important as what we deliver.
 
Our Heart At Work Behaviors™ support this purpose. We want everyone who works at CVS Health to feel empowered by the role they play in transforming our culture and accelerating our ability to innovate and deliver solutions to make health care more personal, convenient and affordable.

As part of the RWE Leadership Team, you are responsible for the overall conduct of real-world evidence research within the Healthspire Life Sciences Solutions organization. You will be committed to the highest standards of scientific and ethical integrity in research and independently provide oversight ensuring that CVS RWE research is conducted with strict ethical principles and in compliance with federal, state, and institutional regulations and policies. You will have deep expertise in all aspects of the conduct of real-world evidence research including the use of secondary data, protection of human subjects in observational research, regulatory compliance, and scientific dissemination and publication. You will oversee all research studies, both retrospective and prospective in design, to ensure compliance with regulations as well as internal guardrails, and ensure that publications and authorship procedures are executed responsibly. You will also serve as the Research Integrity Officer (RIO) where required on federally sponsored research.

You will manage staff including Senior Manager, Quality and Compliance and Lead Director, QA. You will work closely with the teams conducting research to guide on responsible use of data, appropriate IRB submission procedures, and if applicable, informed consent procedures and language. You will be extremely knowledgeable on federal regulations regarding human subject’s research and on best practices in the responsible conduct of real-world evidence studies. You will also become an internal expert on the various CVS Health data sources and represent the RWE group to senior internal stakeholders such as business unit owners to establish and maintain appropriate data governance procedures. You will help identify novel data sources both internally and externally and assist with obtaining the appropriate access and permissions for the use of new data sources. You will work cross-functionally and collaboratively with colleagues from departments such as Legal and Privacy and work well with both scientific and operational colleagues. You are responsible for identifying and reporting any potential research misconduct or data privacy breeches and designing appropriate corrective action plans for any of these issues, in the unlikely event they should occur.

To be a candidate for this role you will possess the following:

Demonstrated ability to build trust, resolve conflict, guide teams who are under pressure, foster collaboration, and maintain effective working relationships.Knowledge of research compliance operations in a healthcare setting.Knowledge of applicable federal, state, and local requirements related to either responsible conduct of research training and education or disclosure of financial interests and outside activities and reporting potential conflicts to sponsors.Strong executive presence and ability to engage with senior leaders. 

Primary Job Duties & Responsibilities:

Establish and ensure compliance with data governance policies and procedures throughout enterprise.Review new and existing research studies and identify regulatory compliance needs, including IRB approach.Supervise staff responsible for quality and compliance.Identify, escalate, and resolve research conduct issues.Identify novel data sources both internally and externally and guide on use of new data.

Required Qualifications

A bachelor’s degree (master's degree preferred) plus 7+ years of professional experience related to the responsible conduct of research.7+ years of experience supervising investigations and staff working with assigned caseloads.7+ years of experience managing quality assurance and compliance process in healthcare.7+ years of experience working with and protecting sensitive and confidential information.7+ years of human subject research experience or real world experience (RWE).

Preferred Qualifications:  

Authorship on publications and/or thought leadership presence on topics relevant to research ethics, best practices in human subjects. Institutional knowledge of the CVS Enterprise and business units.Expertise in real world evidence research.

Education:  

Bachelor’s Degree required.Master’s degree or Doctorate preferred.

Pay Range

The typical pay range for this role is:

$144,200.00 - $288,400.00


This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls.  The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors.  This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.  This position also includes an award target in the company’s equity award program. 
 
In addition to your compensation, enjoy the rewards of an organization that puts our heart into caring for our colleagues and our communities.  The Company offers a full range of medical, dental, and vision benefits.  Eligible employees may enroll in the Company’s 401(k) retirement savings plan, and an Employee Stock Purchase Plan is also available for eligible employees.  The Company provides a fully-paid term life insurance plan to eligible employees, and short-term and long term disability benefits. CVS Health also offers numerous well-being programs, education assistance, free development courses, a CVS store discount, and discount programs with participating partners.  As for time off, Company employees enjoy Paid Time Off (“PTO”) or vacation pay, as well as paid holidays throughout the calendar year. Number of paid holidays, sick time and other time off are provided consistent with relevant state law and Company policies. 
 
For more detailed information on available benefits, please visit jobs.CVSHealth.com/benefits

We anticipate the application window for this opening will close on: 08/26/2024

Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.

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