Job Purpose and Summary:
Study Managers within CVS Clinical Trial Services will manage studies at national level including Sponsor relationships, sourcing needs, and ensuring on-time delivery of protocol milestones.
What you'll do:
● Manage clinical trial site operations nationally to ensure sites meet protocol requirements and have proper infrastructure for trial activities.
● Manage communications with the CRO, subcontractors, and Sponsor.
● Provide weekend on-call rotation support (phone coverage)
● Manage study timelines/draft and finalize project status reports.
● Support Sponsors and CVS Clinical Trial Services BD team with the CVS site selection process based on capacity, location, and individual site capabilities.
● Liaise with Procurement and MinuteClinic operations to ensure required infrastructure is in place and maintained for clinical trial activities and procure supplies as needed.
● Maintain system and study specific trackers to ensure on-time milestone completion and escalate any risks to the Senior Manager Study Management.
● Manage vendor relationships and communications to ensure smooth delivery of clinical trial services.
● Manage long-term study document storage.
● Precept new study managers and coordinators and provide training as necessary.
● Completes feasibility conduct technical assignments and feasibility case for potential studies and present to BD.
● Liaise with Enterprise Initiative Leads and providers for collaboration, performance, and quality of clinical trials.
● Facilitates escalation of quality issues and monitoring findings to appropriate leadership. Management and implementation of operational related CAPAs.
● Tracking study level trends and identifying risks and escalate as appropriate.
● Responsible for management of KPI, KRI, KQI as defined by the Sr. Manager of Study Management and escalate to appropriate stakeholders.
● Identify areas to update SOPs as necessary.
● Hosts audits and inspections at clinical trial site level.
● Responsible for overseeing all site visits including SQV, SIV, and monitoring visits and adhering to outlined CRO monitoring plan. Escalates findings as appropriate.
● Responsible for documenting deviations from SOPs and facilitates appropriate level of approval.
● Create storyboard and ensures that documentation is maintained in the appropriate system. Shares storyboard with leadership and documents risks and decisions.
Who you are:
● Bachelor's degree
● 5+ years of experience managing/coordinating clinical trials to include clinical trial billing and/or budget development.
● Comprehensive knowledge of GCP and ICH guidelines
● Excellent organizational and people skills
● Experience conducting clinical research in chronic disease populations
● Experience managing study activities for multi-center studies
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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