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.

Job Overview:

Exciting opportunity to join our expanding team of Regional Clinical Scientists. The Regional Clinical Scientist will work with the Study Medical Monitor/Study Clinical Scientist and provide scientific and clinical support from ongoing early and late-stage clinical trials with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will also serve as a point of contact for CROs, investigators and study staff in day-to-day safety monitoring under the guidance of the Study Medical Monitor. This individual will report into Global Clinical Operations and will interface directly with the Study Clinical Scientist and other cross-functional team members (including Clinical Development, Global Clinical Operations, Data Management, Biometrics, Patient Safety, Clinical Pharmacology and Biomarkers,) to support clinical study execution and clinical data monitoring.

Responsibilities

• Support Study Clinical Scientist in medical surveillance and medical monitoring activities under the guidance of the Medical Monitor; conduct daily medical surveillance of laboratory & ECG alerts including review of eligibility criteria as appropriate.
• Provides analytical support of clinical trial data, including assessment and follow-up of issues relating to protocol conduct and/or individual subject safety.
• Responsible for gathering, reviewing, and providing preliminary assessments of medical surveillance events to the Study Clinical Scientist and the Study Medical Monitor. Generate study safety events trackers, periodic medical monitoring reports and safety reviews in line with the needs of the study.
• Participate in cross-functional study execution team activities relating to clinical data review.
• Contribute to ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Monitor/Study Clinical Scientist as applicable.
• Interact with internal and external stakeholders (study sites, vendors, etc.) in support of clinical trial objectives related to subject safety and clinical data monitoring; responds to or triages medical and safety-related questions for appropriate actions.
• Performs other duties as assigned related to clinical programs

Qualifications

• Life sciences degree (BS, MS, or Ph.D.) with clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.
• Experience in analysis and interpretation of clinical data (including safety and efficacy); working knowledge of GCP and clinical trial execution.
• Experience working with clinical trial sites.
• Experience in all stages of drug development.
• Ability to make independent, timely and appropriate decisions.
• Ability to handle multiple projects at a time and have a strong attention to detail Excellent oral and written communication skills and solid computer/analytical skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
• High level of organizational and project management skills.
• Flexible to accommodate changes in team and project needs.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 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.

ICON