Abbott
Healthcare
ClinicalSiteLead
Neural analysis suggests this role is
optimal for Lead candidates.
“Clinical Site Lead at Abbott. Skills: Clinical trial execution, Site management, Protocol adherence. Drive study execution. Ensure operational excellence”
What You'll Achieve.
Deliver start-up goals; Achieve study participation levels; Achieve required data quality; Promote patient enrollment; Achieve study goal achievement; Minimize screen failure; Minimize attrition rate
Industry & Context.
Independent problem-solving
Travel 75%, Continuous sitting, Driving, Operating powered equipment
What They're Looking For.
Must Have
Associate's Degree, Minimum 1 year experience
Nice to Have
Bachelor's Degree or Master's Degree, 2+ years clinical trial experience, Cardiology or clinical research experience, Competency in catheterization lab, Competency in operating room protocol, Competency in procedures, Ability to travel approximately 75%
What You'll Do.
Drive study execution
Ensure operational excellence
Serve as recognized resource
Increase product knowledge
Increase disease state knowledge
Provide procedure support
Manage clinical trial enrollment
Apply clinical research
Adhere to site nomination
Adhere to qualification processes
Adhere to startup processes
Lead ongoing training
Retrain site stakeholders
Ensure protocol adherence
Review site recruitment
Manage site data collection
Minimize screen failure
Minimize attrition rate
Ensure compliance with regulatory requirements
Ensure compliance with Good Clinical Practice
Ensure compliance with accuracy standards
Conduct site initiation visits
Conduct periodic visits
Conduct close-out visits
Consult on study design
Consult on site payments
Consult on site audits
Consult on local document review
Consult on study documents preparation
Consult on submission to site
Consult on submission to competent authority
Consult on submission to ethics committee
Develop productive clinical territory
Identify capable sites
Develop capable sites
Maintain capable sites
Assess investigators' interests
Assess investigators' qualifications
Identify appropriate investigators
Maintain open communication
Maintain relationships with key site personnel
Provide ongoing technical support
Facilitate communication between clinical sites
Facilitate communication with Abbott clinical staff
Complete qualification processes
Establish site expectations
Establish sponsor expectations
Facilitate start-up process
Facilitate site initiation visits
Understand regulatory requirements
Understand legal requirements
Develop site-specific enrollment strategies
Promote appropriate patient enrollment
Identify site successes
Identify site challenges
Implement techniques for goal achievement
Evaluate site study performance
Provide feedback to site
Attend study procedures
Attend study follow-ups
Ensure trained personnel attend procedures
Ensure trained personnel attend follow-ups
Develop site-specific deviation strategies
Educate site on compliance tools
Provide feedback on compliance indicators
Escalate non-compliant sites
Collect essential documents
Obtain data corrections
Review adverse events
Review protocol deviations
Review data for accuracy
Review data for completeness
Review source documentation for accuracy
Review source documentation for completeness
Facilitate resolution of data queries
Facilitate resolution of action items
Report findings of monitoring visits
Maintain records of monitoring visits
Apply clinical expertise
Apply technical expertise
Train Abbott staff for clinical trials
Train Abbott staff for commercial launches
Provide clinical expertise for procedure support
Provide technical expertise for procedure support
Collaborate in education of sales groups
Contribute to education of customers
Meet with key customers
Act as resource for technical questions
Act as resource for troubleshooting
Identify shifting priorities
Adapt to shifting priorities
Identify competing demands
Adapt to competing demands
Remain current on developments
Maintain area of expertise
Function as local clinical resource
Function as local technical resource
Possess independent problem-solving skills
How You'll Work.
Team & Collaboration
Site stakeholders; Abbott clinical staff; Clinical sites; Commercial partners; Local sales groups
Communication Scope
Oral communication; Written communication
Full Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. **Summary** The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application. Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. 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. **Main Resp
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