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.

Responsibilities

What will you be doing?

• Works on multiple trials in Oncology
• Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes \xe2\x80\xa2 Mentors/coaches junior flex team
• Acts as Lead SM-training other SMs on study
• Develops site start up documents for studies including SIV agenda
• Provides SM \xe2\x80\x9cvoice\xe2\x80\x9d when reviewing study documents (e.g. Monitoring Guidelines)
• Represents LTMs or SMs on SMTs/meetings
• Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
• Supports country budget development and/or contract negotiation in liaison with CCS colleagues
• Assists with ASV
• Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

Interfaces \xe2\x80\x93 Primary/Other:

• Primary interfaces: Provider Functional Manager, Johnson & Johnson Point of Contact, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
• Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)

Qualifications

What do you need to have?

• Based in the Greater Toronto Area, ON
• Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
• Have a minimum of 3 years\xe2\x80\x99 experience in monitoring pharmaceutical industry clinical trials
• Knowledge of several therapeutic areas, including oncology \xe2\x80\x93 preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
• Analytical/risk-based monitoring experience is an asset
• Ability to actively drive patient recruitment strategies at assigned sites
• Ability to partner closely with investigator and site staff to meet all of our study timelines
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
• Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• Need to travel up to 50%
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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