Senior Clinical Monitoring Lead

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Employees 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 contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A 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 Fortune
• A 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 scientists

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.

• Serve 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.

• Provide 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.

• Partner 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.

• Lead 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.

• Bachelor’s degree or an equivalent combination of education and work experience
• 5 years’ experience in a clinical research environment or other equivalent experience
• Knowledge of regulations and standards (Good Clinical Practices) for conducting clinical research. 
• Polished communicator: written documentation and oral presentations/discussions/meetings
• Ability 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 detail
• Experience and training on GCP 

• 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 specialist
• 5 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.

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