Study Manager

ICON plc • Montreal, QC

9d • Remote

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and excellence. The Study Manager role supports the SM Study Lead and study team with the operational conduct of clinical studies. This may involve assisting with CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, and study closeout activities. The position may support a single study or multiple studies, or even lead a study with limited scope, such as Survival Follow-up. Key responsibilities include tracking study timelines, utilizing project management tools, and interacting with various internal and external stakeholders like study sites, vendors, and committees to achieve clinical study objectives.

Requirements

• BS/BA/MS/PhD with 2+ yrs clinical research experience
• Experience with managing imaging vendors/ reading centers, biomarker sample collection and management for ophthalmology clinical
• Experience with ophthalmologic assessments, e.g. (imaging assessments such as optical coherence tomography OCT}; fluorescein angiography FA}, spectral domain optical coherence tomography and visual acuity assessments such as best corrected visual acuity BCVA} performed in ophthalmology clinical trials.
• Experience with DME and RVO diseases.
• Demonstrated oral and written communication skills
• Excel and PP experience required
• Applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status

Nice To Haves

• Pharmaceutical and/or clinical drug development experience

Responsibilities

• Assists the SM Study Lead and study team with the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities)
• May support a single study or multiple studies
• May lead a study with limited scope (e.g., Survival Follow-up)
• May be responsible for tracking study timelines and will be proficient in project management tools
• May interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees