Clinical Project Manager/ Clinical Trial Manager (On Site- Lake Forest, IL)

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and 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 and named one of the most admired companies in the world by Fortune.
• A company that is 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.

The Opportunity

This position works daily out of our Lake Forest, IL 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