Job Description

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position Summary

The Clinical Operations Study Lead is responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The COSL is expected to address site and vendor-related issues, with assistance as needed.

Responsibilities

• Develops and oversees study operational plan(s)
• Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
• Assists with protocol design and strategy and medical issue resolution,
• Participates in study data review and assists with patient narrative writing and other data review activities as assigned.
• Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports
• Proactively identifies project risks and resolves with some supervision
• Participates in the selection of Investigators and vendors
• May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
• Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team
• Performs other duties as assigned

Qualifications

Technical and Communicative Skills:

• Strong study management track record showing clear proficiency in clinical project management skills. Solid vendor management skills
• Broad understanding of operations including those in related development functions
• Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
• Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
• Demonstrates ability to lead multi-disciplinary teams
• Possesses excellent written and oral communications skills

Preferred Education and Experience:

• M.S. (or equivalent experience) and 4+ years of relevant work experience
• B.S. (or equivalent experience) and 6+ years of relevant work experience

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.