CVS Health
Remote/Telecommute
Clinical Trials - Senior Advisor Business Compliance
Posted over 1 month ago
Job Description
Job Description
** Position can be Full Time Work From Home in any US location**
MUST HAVE CLINCAL TRIALS EXPERIENCE
As a Sr. Advisor for the Business Compliance Office (BCO) located within the CVS Health Corporate Compliance Division, the individual will be collaborating with a team that will monitor and implement compliance initiatives throughout the CVS Health enterprise. Additionally, responsibilities will include owning relationships with business owners and key stakeholders to ensure processes are enhanced or implemented to effectively address compliance requirements.
As a key part of the Business Compliance Office the individual will track, analyze, and interpret compliance performance to support best in class results. This position will work independently as well as in collaboration with colleagues from across the organization. They will work with and influence decision makers within Compliance, Legal, and Operations across all business segments. A key role of this position is working with business partners to develop and implement compliance strategies.
** Position can be Full Time Work From Home in any US location**
As a Sr. Advisor for the Business Compliance Office (BCO) located within the CVS Health Corporate Compliance Division, the individual will be collaborating with a team that will monitor and implement compliance initiatives throughout the CVS Health enterprise. Additionally, responsibilities will include owning relationships with business owners and key stakeholders to ensure processes are enhanced or implemented to effectively address compliance requirements.
As a key part of the Business Compliance Office the individual will track, analyze, and interpret compliance performance to support best in class results. This position will work independently as well as in collaboration with colleagues from across the organization. They will work with and influence decision makers within Compliance, Legal, and Operations across all business segments. A key role of this position is working with business partners to develop and implement compliance strategies.
Oversight
- Maintain an in-depth knowledge and subject matter expertise of federal regulatory framework governing human subject research and the responsible conduct of research. Coordinate with Business, Legal and Regulatory partners to identify applicability to the business segments.
- Provide support and oversight for new and ongoing clinical research studies.
- Actively participate in applicable business working groups/committees for areas of responsibility
Surveillance
- Lead the compliance effort with CVS Health business segments to implement processes or programs to comply with any new law or regulation pertaining to areas which include claim adjudication and government billing
- Monitor Regulatory and Industry environment for new and emerging regulations or changes and industry best practices/Standards
Assurance
- Develop, conduct and participate in risk-based auditing and assessment of clinical trial studies.
- Be the compliance lead in implementing solutions with applicable business partners in regards to any findings identified during Compliance Risk Assessments, Corrective and Preventive Actions
- Implement mitigation plans and monitor business segment compliance clinical trial protocols. Drive compliance of initiatives to completion and validate their effectiveness.
- Act as a BCO lead in Risk Assessments on Subject Matter areas to identify regulatory risks, business controls, and establish Compliance oversight.
Required Qualifications
* 7 years of clinical trial oversight experience or similar work experience
* In-depth understanding of regulatory framework related to clinical trials, including GCP practices, FDA, and ICH
* Experience with quality support and oversight of global clinical trials and drug development operations.
* Strong program management and effective communications, including the ability to interact and influence decisions at various levels of the organization.
* 5 years experience providing quality reviews, verify the effectiveness of compliance controls and assess risk mitigation strategies.
Preferred Qualifications
* 10 years of clinical trial oversight experience or similar work experience.
* Advanced degree.
* CHC, CHC-R, ASQ-CQA or similar.
* Previous experience with legislation and/or regulatory research.
#LI-DI1
Education
Bachelors Degree or equivalent work experience
Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
** Position can be Full Time Work From Home in any US location**
MUST HAVE CLINCAL TRIALS EXPERIENCE
As a Sr. Advisor for the Business Compliance Office (BCO) located within the CVS Health Corporate Compliance Division, the individual will be collaborating with a team that will monitor and implement compliance initiatives throughout the CVS Health enterprise. Additionally, responsibilities will include owning relationships with business owners and key stakeholders to ensure processes are enhanced or implemented to effectively address compliance requirements.
As a key part of the Business Compliance Office the individual will track, analyze, and interpret compliance performance to support best in class results. This position will work independently as well as in collaboration with colleagues from across the organization. They will work with and influence decision makers within Compliance, Legal, and Operations across all business segments. A key role of this position is working with business partners to develop and implement compliance strategies.
** Position can be Full Time Work From Home in any US location**
As a Sr. Advisor for the Business Compliance Office (BCO) located within the CVS Health Corporate Compliance Division, the individual will be collaborating with a team that will monitor and implement compliance initiatives throughout the CVS Health enterprise. Additionally, responsibilities will include owning relationships with business owners and key stakeholders to ensure processes are enhanced or implemented to effectively address compliance requirements.
As a key part of the Business Compliance Office the individual will track, analyze, and interpret compliance performance to support best in class results. This position will work independently as well as in collaboration with colleagues from across the organization. They will work with and influence decision makers within Compliance, Legal, and Operations across all business segments. A key role of this position is working with business partners to develop and implement compliance strategies.
Oversight
- Maintain an in-depth knowledge and subject matter expertise of federal regulatory framework governing human subject research and the responsible conduct of research. Coordinate with Business, Legal and Regulatory partners to identify applicability to the business segments.
- Provide support and oversight for new and ongoing clinical research studies.
- Actively participate in applicable business working groups/committees for areas of responsibility
Surveillance
- Lead the compliance effort with CVS Health business segments to implement processes or programs to comply with any new law or regulation pertaining to areas which include claim adjudication and government billing
- Monitor Regulatory and Industry environment for new and emerging regulations or changes and industry best practices/Standards
Assurance
- Develop, conduct and participate in risk-based auditing and assessment of clinical trial studies.
- Be the compliance lead in implementing solutions with applicable business partners in regards to any findings identified during Compliance Risk Assessments, Corrective and Preventive Actions
- Implement mitigation plans and monitor business segment compliance clinical trial protocols. Drive compliance of initiatives to completion and validate their effectiveness.
- Act as a BCO lead in Risk Assessments on Subject Matter areas to identify regulatory risks, business controls, and establish Compliance oversight.
Required Qualifications
* 7 years of clinical trial oversight experience or similar work experience
* In-depth understanding of regulatory framework related to clinical trials, including GCP practices, FDA, and ICH
* Experience with quality support and oversight of global clinical trials and drug development operations.
* Strong program management and effective communications, including the ability to interact and influence decisions at various levels of the organization.
* 5 years experience providing quality reviews, verify the effectiveness of compliance controls and assess risk mitigation strategies.
Preferred Qualifications
* 10 years of clinical trial oversight experience or similar work experience.
* Advanced degree.
* CHC, CHC-R, ASQ-CQA or similar.
* Previous experience with legislation and/or regulatory research.
#LI-DI1
Education
Bachelors Degree or equivalent work experience
Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.
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