JOB DESCRIPTION:The Opportunity The Senior Clinical Monitoring Lead (CML) serves as the regional subject matter expert for clinical monitoring quality, oversight, and execution. This role partners with Clinical Site Management Leadership to drive monitoring excellence through report quality review, monitoring performance oversight, training, mentoring, compliance support, and continuous process improvement initiatives.The Senior CML provides leadership and support to Clinical Site Leads across the region, helping ensure consistent execution of monitoring plans, regulatory compliance, timely issue resolution, and adherence to company standards. As a recognized monitoring expert, the Senior CML acts as a key liaison among field monitoring teams, study teams, and quality functions to support operational effectiveness and inspection readiness.As a recognized subject matter expert in Site Quality Monitoring, KCI process, SIV, PMV, and COV, the Senior CML will exhibit fluency on monitoring-related clinical data systems and study-specific Monitoring Plans. Along with monitoring their own assigned sites, the Senior CML will provide direct mentorship on monitoring training, execution, and best practices for all Clinical Site Lead’s throughout the region and also serve as a liaison to Field Clinical Quality Managers.May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee. Beyond monitoring assigned sites, the Senior CML is a nationally recognized leader/expert in monitoring who provides support, mentoring and guidance to other clinical site management colleagues and consistently delivers prolific contributions to Global Clinical Operations and/or Business Units.What You’ll Work On Monitoring Oversight & ComplianceServe as a regional monitoring expert providing oversight of monitoring quality, monitoring documentation, and compliance with study requirements, GCP, and company procedures.Review and provide feedback on monitoring visit reports, monitoring trends, and quality metrics to promote consistency and continuous improvement.Support CAPA activities, issue escalation management, inspection readiness initiatives, and monitoring-related quality investigations.Training & DevelopmentProvide mentoring, coaching, onboarding, and ongoing support to Clinical Site Leads and monitoring personnel.Lead or contribute to monitoring-focused training initiatives and best practice sharing across the organization.Monitoring Operations LeadershipPartner with study teams, regional leadership, and quality functions to identify risks, monitor performance metrics, and drive resolution of monitoring-related issues.Support development and maintenance of monitoring tools, processes, guidance documents, and operational resources.Strategic ContributionsLead or support continuous improvement initiatives that enhance monitoring effectiveness, quality, compliance, and operational efficiency.Serve as a monitoring subject matter expert for special projects, audits, inspections, and cross-functional initiatives.Required Qualifications: Bachelor’s degree or an equivalent combination of education and work experience5 years’ experience in a clinical research environment or other equivalent experienceKnowledge of regulations and standards (Good Clinical Practices) for conducting clinical research. Polished communicator: written documentation and oral presentations/discussions/meetingsAbility to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in timely manner.Strong organizational and follow-up skills, as well as attention to detailExperience and training on GCP Preferred Qualifications: Bachelor’s degree in Engineering, Biological Sciences, Nursing, or a related field OR equivalent or related experience in cardiology or clinical research.2 years’ experience as a field clinical monitor specialist5 years relevant clinical trial experience in the cardiovascular and/or Neuromodulation field.3 years’ experience as clinical monitor.5+ years of medical device experience.Experience with GCP, ISO standards, and clinical trial guidelines.Flexibility to work across all US time zones.Demonstrated experience mentoring, training, or leading monitoring personnel.Experience supporting monitoring oversight, quality systems, CAPA management, audit readiness, or inspection support activities.Demonstrated ability to analyze monitoring metrics and identify opportunities for process improvement.The base pay for this position is $78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.Training & DevelopmentCareer development with an international company where you can grow the career you dream ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsAbout UsAbbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Senior Clinical Monitoring Lead

Emma

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