Clinical Study Coordination Senior Manager - Clinical ...

Job DescriptionCVS Clinical Trial Services, a 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 Clinical Study Coordination Senior Manager will supervise Clinical Research Coordinators in various aspects of study start-up and execution of clinical research, including feasibility assessment, regulatory functions, patient study visit management, data entry and quality assurance, and is responsible for oversight of monitoring visits and audits. Reporting directly to the Executive Director, Patient Care Delivery Operations, the Clinical Study Coordination Senior Manager will also oversee special projects. What you'll do:● Implement a diverse portfolio of study coordinator research activity responsibilities for all studies which may include multiple sites for each study, clinical research activities and clinical database to ensure overall progress on each project. Tracks study specific milestones.● Hiring, onboarding, formally supervise, train, mentor, scheduling, and preparation of performance evaluations. ● Facilitate ongoing training, professional development, and continuing education ● Assess workload, including assignment of new study responsibilities, to balance capacity and achieve the highest level of quality.● Lead and be a resource for others on local regulations, laws, and guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) to achieve inspection readiness and detect and resolve quality issues.● Build, communicate, and execute site and country-level risk mitigation and contingency plans.● Act as team super-user or subject matter expert for related systems and processes; provide presentations, training, and support to study coordinator team as needed; provide updates to applicable resources as needed.● Monitor study enrollment goals and determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Facilitates best practices to enhance study coordinator local recruitment skills. ● Audit study coordinator operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.● Collaborate with principal investigators and study sponsors as needed ● Ensure regulatory compliance; utilize dashboards and measurements to facilitate compliance● Support multiple staff members who will be working remotely for the most part, including data entry managersPay RangeThe typical pay range for this role is:Minimum: 75,400Maximum: 158,300Please 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.Required Qualifications● 7+ years' experience in Phase 2-4 Clinical Trials/Development and RWE studies, across multiple therapeutic areas and managing study activities for multi-center studies to include supporting site qualifications visit and sponsor qualification audits● 5+ years' experience working with pharmaceutical sponsors, CROs and external vendors for execution of clinical trials, with the understanding of GCP, ICH and applicable regulatory standards governing clinical research.● 4+ years of experience in supervision, coaching, and mentoring others● 2+ years of experience using clinical trial technology including CTMS, IRT, ePRO or equivalent technology● Ability to travel off site locations up to 50% of timeCOVID RequirementsCOVID-19 Vaccination RequirementCVS 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● Ability to provide program-level direction, guidance, and support in development of study strategy operational plans including enrollment models and risk management strategy.● Familiarity with Clinical Trial study site services budgeting. ● Knowledge of medical terminology; ability to communicate research goals effectively and clearly to leadership, research team, support staff, etc.● Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.EducationBachelors degree or equivalent experienceBusiness OverviewBring 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. 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.

Created: 2025-11-15