Senior Clinical Project Specialist - Structural Heart

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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

Our Structural Heart business currently has an opportunity for a Senior Clinical Project Specialist. This position is part of our Study Operations Project Management team. You will participate in the execution of Abbott clinical device studies. Working to ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. Dedicated focus is on study management support activities which may include vendor oversight.

What You’ll Work On

• Supports Clinical Project Manager in key study execution tasks
• Responsible for maintaining study specific SharePoint sites and study level TMF
• Develops and owns study-specific materials such as training slides, document templates (i.e. DoA, training logs), and newsletters.
• Assists with development of study-related materials such as: SIV slides, patient brochures, patient recruitment material, and presentations.
• Reviews Site Activation Checklist to ensure all required elements and documents are included.
• Assists with site selection processes.
• Coordinates activities with study specific committees, vendor services, and core labs.
• Reviews documents (e.g. study document templates and site activation regulatory documents) for accuracy and completeness. 
• Provides periodic updates on site and/or study statuses, as requested by the Clinical Project Manager
• As applicable, communicate effectively with Customers/KOLs, Physician Members, National Principal Investigators, Field Clinical, Medical Directors, and Clinical Science, Research and Development, and other internal personnel.

Education and Experience

Required:

• Bachelor's degree. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field. 
• Minimum 3 years in clinical operations or healthcare related field. Medical training/background highly beneficial
• Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem-solving skills.  Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.
• Proficiency in Microsoft Office Suite and relevant clinical applications.