Study Manager
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Job Description
Study Manager supporting operational conduct of clinical studies in ophthalmology. Collaborating with teams and managing timelines for clinical drug development.
Responsibilities:
- Support 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.
Requirements:
- BS/BA/MS/PhD with 2+ yrs clinical research experience
- Pharmaceutical and/or clinical drug development experience beneficial but not required
- 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.
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.
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