This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof.
Responsible for the operational planning, feasibility, and execution of a clinical trial.
May serve as the clinical trial team lead
May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities).
Leads team for timeline management, risk identification and mitigation, issue resolution.
May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives.
Accountable for managing any study specific partners and/or vendors.

Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree
Degree in life sciences, preferred
Experience in conducting global clinical trials, including trial initiation through database lock
Highly Preferred: experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease
Experience in managing and driving operational activities on protocols for ophthalmology clinical trials.
Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee for ophthalmology clinical trials.
Experience in managing imaging vendors for ophthalmology clinical trials
Experience with ophthalmologic assessments, e.g. (slit lamp, dilated indirect ophthalmoscopy {DIO}, imaging assessments such as optical coherence tomography {OCT}; fluorescein angiography {FA}, fundus photography {FP} and visual acuity assessments such as best corrected visual acuity {BCVA}) performed and as well as supplies and equipment needed at sites in ophthalmology clinical trials.

Senior Scientist, Study Manager

Key skills