Senior Clinical Project Specialist

Senior Clinical Project Specialist - Structural Heart 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. 

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 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 

Manage all aspects of subject selection committee work 

Tracking and results-oriented communication of data entry needs/ timelines to sites, core labs, and colleagues 

Leveraging knowledge of specific protocol and committee charter requirements (i.e. inclusion/exclusion criteria and procedural requirements) with ability to resolve discrepancies prior to committee review 

Facilitate timely committee member adjudications via offline email review and/or live teleconference review calls between committee members, site investigators, and internal stakeholders 

Work with site and core lab to process images and if applicable to help sites to prepare slides for review meetings 

Frequently communicate review status, including final adjudication results, to site investigators and research staff, and field clinical personnel 

Track committee member consulting time to facilitate consultant billing 

Ensure good documentation practices by timely database documentation of committee decision, archival of supporting documentation, as well as, note to file generation when needed 

Collaborate with clinical study and field teams to track all prospective committee cases 

Provide feedback for applicable study protocol sections, training plans, and presentations, as well as contributing to committee charter creation and subsequent revisions 

Manage trial timelines and deliverables for annual database locks with study team and sites 

Required Qualifications: 

• Asociates Degree (± 13 years) 

• Minimum 7 years related experience  

Education and Experience:  

• 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. 

• The ability to work independently when necessary. 

• The ability to exchange straightforward information, ask questions, and check for understanding. 

• A general familiarity with cardiac, vascular technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment. 

• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP). 

• Work habits include organization, coordination of many tasks, accuracy, and attention to detail.