[Hiring] Senior Clinical Monitoring Lead @Abbott

Role Description

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 and mentoring
• Compliance support
• Continuous process improvement initiatives

The Senior CML provides leadership and support to Clinical Site Leads across the region, ensuring:

• Consistent execution of monitoring plans
• Regulatory compliance
• Timely issue resolution
• Adherence to company standards

As a recognized monitoring expert, the Senior CML acts as a key liaison among:

• Field monitoring teams
• Study teams
• Quality functions

May be consulted in the following areas:

• Study design
• Site payments
• Site audits
• Local document review
• Study documents preparation
• 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.

Qualifications

• 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
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in a timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Experience and training on GCP

Requirements

• 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

Benefits

• Career development with an international company
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement and education benefits
• Recognized as a great place to work in multiple countries
• Named one of the most admired companies in the world by Fortune
• Recognized as one of the best big companies to work for and for diversity