[Hiring] Clinical Monitoring Lead @Abbott

Role Description

The Clinical Monitoring Lead (CML) supports clinical monitoring quality, oversight, and execution within an assigned region. This role partners with Clinical Site Management Leadership to support monitoring excellence through:

• Monitoring activities
• Compliance support
• Monitoring documentation review
• Issue resolution
• Continuous improvement efforts

The CML collaborates with Clinical Site Leads, study teams, and quality partners to ensure:

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

The CML demonstrates proficiency in:

• Site Quality Monitoring
• KCI process
• SIV, PMV, and COV activities
• Monitoring-related clinical data systems
• Study-specific Monitoring Plans

In addition to monitoring assigned sites, the CML supports:

• Monitoring training
• Execution
• Best practice implementation throughout the region

The CML may be consulted in:

• Study and CRF design
• Site audits
• Local document review
• Study document preparation

The CML contributes to successful study execution by supporting high-quality monitoring practices, compliance, and operational effectiveness.

Qualifications

• Bachelor's degree or an equivalent combination of education and work experience
• 3 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 communication skills with ability to effectively communicate at multiple levels in the organization
• Ability to multitask, prioritize, and meet 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
• 3 to 5 years of relevant clinical trial experience in the cardiovascular and/or Neuromodulation field
• 2+ years of medical device experience
• Experience with GCP, ISO standards, and clinical trial guidelines
• Flexibility to work across all U.S. time zones
• Experience supporting monitoring activities, monitoring quality, compliance initiatives, audit readiness, or inspection support activities
• Demonstrated ability to evaluate monitoring activities 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 in the next calendar year
• Excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• Freedom 2 Save student debt program
• 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 worldwide
• Named one of the most admired companies in the world by Fortune
• Recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists