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.Youllalso 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 bachelors degree.

A company recognized asa great placeto 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 Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whetheritsglucose 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 than10000 peoplehave healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than500000 peoplewith diabetes from routinefingersticks.

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 willparticipatein the execution of Abbott clinical device studies. Working to ensure compliancetostudy 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.

WhatYoullWork 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

Facilitatetimelycommittee 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 tofacilitateconsultant billing

Ensure good documentation practices bytimelydatabase documentation of committee decision archival of supporting documentationas well asnote 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 andsubsequentrevisions

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

Required Qualifications:

• AsociatesDegree( 13years)

• Minimum 7 years related experience

Education and Experience:

• Bachelors degree. Preferably with an academic focusinnatural 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 havedemonstratedstrong written and verbal communication interpersonal presentation analytical organizational technical writing and problem-solving skills. Able to interpret clinical data meetdeadlinesand work effectively with all levels of employees.

• Proficiencyin Microsoft Office Suite and relevant clinical applications.

• The ability to work independently whennecessary.

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

• A general familiarity withcardiacvascular technologies.Previousrelated 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.