Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).
Serving as the lead clinical scientist on the clinical trial team.
Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
Providing tactical/scientific mentorship to other clinical scientists.

Requirements

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.
Experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease.
Experience in developing protocols and study related documents 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 with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in ophthalmology clinical trials.
Experience in performing medical monitoring in 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 in ophthalmology clinical trials.

Benefits

medical
dental
vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical protocol executionmedical monitoringclinical data interpretationprotocol developmentCRF designdata collectionclinical trial managementophthalmology clinical trialsbiomarker sample managementmedical monitoring in ophthalmology

Soft Skills

leadershipcollaborationmentorshipcommunicationproject management