Clinical Project Specialist - Medical Devices (Onsite)

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 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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

We are seeking a Clinical Project Specialist to join our Clinical Operations team on-site in Sylmar, CA for Medical Devices. This new team member will provide clinical operational support for multiple cardiac clinical studies and projects as well as serve as a liaison to the clinical project manager; and other departments and external suppliers; and provides logistical support to the clinical research teams. Additionally, performs responsibilities meeting project commitments and in compliance with applicable procedures, regulations and standards.

What You’ll Work On

• Conduct assigned clinical operation activities under the supervision of Clinical Project Manager and in accordance with applicable regulations; GCP; and Division policies and procedures. May include the following activities:
• Coordinate the creation of clinical study materials for selection, qualification and activation of clinical study sites.
• Manage study-level communication with sites, e.g. share Newsletters, annual/final reports.
• Partner with Marketing to develop Diversity and Inclusion patient access materials
• Coordinate study close out process.
• Coordinate the global review and approval process for site activation
• Ensure audit readiness for assigned studies.
• Prepare study newsletters.
• Complete Central IRB submissions.
• Routing of documents for signature.
• Define clinical study SharePoint structure and maintain site.
• Develop document management plan and maintain at the study level; including setup of individual studies and uploading documentation.
• Support management of 3rd party suppliers/corelabs and tracking of their deliverables.

Required Qualifications

• Bachelor's degree required
• Minimum of 2 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
• Good knowledge and application of business concepts, procedures and practices.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Learns to use professional concepts and company policies and procedures to solve routine problems.
• Works on problems of limited scope. Minimal independent decision making.

Preferred Qualifications

• Bachelors in Biological Science or Medical Specialty preferred
• Knowledge of regulations and standards (GCP) affecting implantable medical devices.
• Ability to work in a 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 communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.