JOB DESCRIPTION:The OpportunityThe
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, and continuous improvement efforts.
The CML collaborates with Clinical Site Leads, study teams, and quality partners to support consistent execution of monitoring plans, regulatory compliance, timely issue resolution, and adherence to company standards. The CML serves as a key monitoring resource, helping ensure high-quality monitoring practices and inspection readiness across assigned studies.
The CML demonstrates proficiency in Site Quality Monitoring, KCI process, SIV, PMV, and COV activities and develops expertise in monitoring-related clinical data systems and study-specific Monitoring Plans. In addition to monitoring assigned sites, the CML supports monitoring training, execution, and best practice implementation throughout the region while collaborating with Field Clinical Quality Managers and cross-functional study teams.
May be consulted in the following areas: study and CRF design, site audits, local document review and study document preparation. The CML contributes to successful study execution by supporting high-quality monitoring practices, compliance, and operational effectiveness.
What You'll Work OnMonitoring Oversight & Compliance- Monitor clinical studies at sites within an assigned territory (and others as requested) to ensure compliance with study requirements, Good Clinical Practice (GCP), applicable regulations, and company procedures.
- Review monitoring documentation and monitoring activities for quality, completeness, and compliance with study requirements.
- Support monitoring issue identification, escalation, and resolution activities.
- Contribute to inspection readiness activities and support monitoring-related quality initiatives.
- Assist with review of monitoring trends and quality metrics to support consistency and continuous improvement.
Training & Collaboration- Support onboarding and training of Clinical Site Leads and monitoring personnel on monitoring processes.
- Participate in monitoring-focused training initiatives and sharing of best practices.
- Collaborate with study teams, Clinical Site Leads, and quality partners to address monitoring-related questions and issues.
Monitoring Operations- Partner with study teams and regional leadership to support monitoring performance, quality objectives, and study execution goals.
- Support implementation and maintenance of monitoring tools, processes, and operational resources.
- Identify opportunities to improve monitoring quality, efficiency, and consistency.
- Escalate significant compliance or quality concerns according to company policies and procedures.
Continuous Improvement- Participate in projects and initiatives that improve monitoring effectiveness, quality, compliance, and operational efficiency.
- Support audit, inspection, and quality-related activities as requested.
- Remain current on clinical research regulations, GCP requirements, monitoring practices, and applicable therapeutic-area knowledge.
Required 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.
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.
- 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.
Apply Now
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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Clinical Affairs / Statistics
DIVISION:MD Medical Devices
LOCATION:United States of America : Remote
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 25 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday)
