The Clinical Quality and Compliance Senior Manager is responsible for partnering with the CVS Health Clinical Trial Services (CTS) Business areas, Real World Evidence, Safety and Collaboration and Patient Recruitment functions to set the strategy and plans for embedding Quality and Compliance across the business units. This role will have accountability for implementing operational requirements for regulatory compliance. Additionally, the Quality and Compliance Integrations Senior Manager will play a vital role as a member of the Quality leadership team.
What you'll do:
• Integrate quality throughout the RWE/S&C and Recruitment business areas.
• Lead Inspections and audits with Health Authority and Partners including hosting, managing, and responding to audit and inspection findings.
• Establish and maintain the programs, policies, and procedures; ensuring compliance to applicable regulations, guidance and laws.
• Drive improved compliance and quality of business unit operations and processes, tracking and trending key metrics, and utilizing data to embed continuous improvement principles across business units.
• Serve as the quality business partner with internal and external business units including Compliance, Legal, Privacy, vendors, sponsors.
• Primary accountability for compliance and performance of vendors, contract facilities and contract service providers.
• Understand and interpret regulatory agency policies and guidance as it pertains to work conducted.
• Ensure compliance with applicable health authority regulations and guidelines for document management including technology applications.
• Responsible for writing and maintaining Policies and Procedures (P&P's) as required, working with cross functional leadership to ensure compliance.
• Accountable for the QA review of documentation and documents submitted to regulatory agencies, including IRBs, Sponsors, Publications.
• Monitor current and projected quality issues and advise management on events of significance for CTS business interests.
The typical pay range for this role is:
Please keep in mind that this range represents the pay range for all positions in the job grade within which this position falls. The actual salary offer will take into account a wide range of factors, including location.
• 8 years' experience with data and analytics, recruitment, or relevant experience in a GxP environment
• 3 years' experience in a Quality/Regulatory/Quality Assurance role, preferably in a Data setting and comprehensive knowledge of Health Economics and Outcomes Research (HEOR), Safety Surveillance, Phase 4 clinical research, GCP, ICH, and other regulations for pharmaceuticals
COVID-19 Vaccination Requirement
CVS Health requires certain colleagues to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, religious belief, or other legally recognized reasons that prevents them from being vaccinated.
You are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status or apply for a reasonable accommodation within the first 10 days of your employment. Please note that in some states and roles, you may be required to provide proof of full vaccination or an approved reasonable accommodation before you can begin to actively work.
• IRB experience
• Experience in developing business strategies, policies and procedures, metrics, and continuous improvements
Bachelors degree required or equivalent experience
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.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day.
CVS Health is an affirmative action employer, and is an equal opportunity employer, as are the physician-owned businesses for which CVS Health provides management services. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Perks and Benefits
Health and Wellness
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- HSA With Employer Contribution
- Wellness Program
- Pet Insurance
- Mental Health Benefits
Parental Benefits and Childcare
- Paid Family Leave
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Flexible Work Hours
- Remote Work Opportunities
- Hybrid Work Opportunities
Office Life and Perks
- Employee Resource Groups (ERG)
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
Financial and Retirement
- 401(K) With Company Matching
- Tuition Reimbursement
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program