Regional Clinical Scientist - Home-Based (US or Canada)

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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, colour, 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 or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.