Key skills
Project Management
About this role
Role Overview
- 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);
- monitoring 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 for Gastroenterology, Dermatology, Rheumatology, or ophthalmology, especially autoimmune or immune-mediated disorders.
- experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria)
- experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
- strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
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