Posted:
11/25/2024, 1:53:37 PM
Location(s):
Illinois, United States ⋅ Maine, United States ⋅ South Portland, Maine, United States ⋅ Lake Forest, Illinois, United States
Experience Level(s):
Senior
Field(s):
Business & Strategy ⋅ Product
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
The Opportunity
This position works daily out of our Lake Forest, IL or South Portland, Maine location in the Rapid Diagnostics, Infectious Disease division. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
What You’ll Work On
Oversees clinical monitoring activities of both small and large-scale clinical trials
Effectively lead the operational clinical team for assigned studies and delegate appropriate tasks, assignments, and responsibilities to subordinates.
Provide feedback on study/protocol design as needed
Promotes operational efficiency teamwork among CRAs
Supervises study project team
Communicates monitoring and site management updates and issues to team; escalates monitoring-related study timeline and quality risks to Clinical Program Manager/Clinical Project Lead
Collaborate with the Legal Department to develop study contract templates across the trial and specifically for each study site.
Proactively prevents and identifies issues related to monitoring or site issues
Proficient use of, and capability to train others, on ECD systems; ability to create Case Report Forms and protocol-specific edit checks
Creates and maintains monitoring tracking tools and develops study tools and templates for CRAs and site personnel
Develops the Site Monitoring Plan and ensures CRA compliance with the plan
Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
Participates in site start-up activities including site selection and regulatory document collection, review, approval and tracking; development of informed consent forms /assent forms as applicable
Creates study template documents, regulatory binder and other study related documents
Develops study-specific CRA training materials. Trains CRA team and tracks and maintains documentation of training throughout the project
Qualifies, reviews and manages CROs and study suppliers
Works closely with CA department management for resourcing issues and escalates pertinent CRA performance and site compliance issues when necessary
Additional project and tasks as determined by department and organizational needs
Technical skills/Knowledge/Abilities
Advanced knowledge of clinical trial practices and regulations.
Advanced knowledge of clinical trial, design, clinical trial databases, and data analysis clinical trials.
Proficient computer skills including Microsoft Office Suite.
Required Qualifications
Minimum BA or BS in Science or similar field of study
5 or more years of related experience in a similar role.
Willingness to travel for job related activities if required (Travel may be approximately 20%).
Preferred Qualifications
At least one year of previous experience as a manager in previous role.
8 or more years of experience is preferred.
Medical/Pharma background in overseeing clinical trials preferred
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is
$72,700.00 – $145,300.00In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Website: https://abbott.com/
Headquarter Location: Illinois City, Illinois, United States
Employee Count: 1001-5000
Year Founded: 1944
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Emergency Medicine ⋅ Genetics ⋅ Health Care ⋅ Health Diagnostics ⋅ Manufacturing ⋅ Medical ⋅ Medical Device ⋅ Nutrition ⋅ Pharmaceutical