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Job Details


CVS Health

Regional Site Manager - Clinical Trial Services (2099826BR)

Pharmaceuticals

All

Yearly

No

Georgia, United States

Job Description
CVS Clinical Trial Services™, a new CVS Health company, is part of the company’s portfolio of initiatives to advance and transform health and healthcare. As we redesign and innovate trial delivery and real-world evidence generation, we put the patient at the heart of everything we do. We are a dynamic team who have the benefit of operating in an entrepreneurial environment where bold thinking and novel approaches are not only rewarded, but they are also encouraged. Ownership and the ability to shape the way forward is empowered at all levels to accelerate progress and innovation. Here, colleagues work not only within our organization but across the CVS Health matrix, acting as one team to achieve our goals, deliver solutions and transform the future.

The Regional Site Manager (RSM) within CVS Clinical Trial Services will oversee all study related site activities at a cluster of sites within a designated region. The RSM will work collaboratively with head of Site Nursing, head of Clinical Research Coordinating (CRC) and head of Research Pharmacy (RPh) to ensure all site resourcing needs are met and ensure on-time delivery of study protocol requirements and milestones.

What you'll do:

• Oversee clinical trial site operations regionally to ensure site conduct meets protocol requirements and have proper infrastructure to meet required study activities.
• Provide oversight and direction to site study team members for study deliverables.
• Support Feasibility Lead in assessment to include selection and finalization of sites for study conduct.
• Manage implementation of site specific operational related CAPAs.
• Collaborates regularly with PI and designated PI staff assigned to preserve conduit of continuity between PI sites and CVS sites.
• Oversee all site visits including SQV, SIV, and monitoring visits and adhering to outlined CRO monitoring plan. Escalates findings as appropriate.
• Ensure availability and implementation of general operations and study specific training; coordinate operational and therapeutic area training for internal team members

Required Qualifications
• 5 years of clinic and/or health care experience
• 5+ years of GCP and ICH guidelines experience managing/coordinating clinical trials activity in a research site setting include hiring and managing staff, overseeing operations and quality.

COVID Requirements


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.

Preferred Qualifications
• Experience managing study activities for multi-center studies

Education
Bachelor's degree, or equivalent experience

Business Overview
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.