Clinical Development Scientist
Core
Performs high-quality clinical data review and identifies insights to ensure data scientific plausibility, safety, and trend analysis for global clinical trials.
Role type
Clinical Development Scientist (Clinical Scientific Expert I)
Builds
Global clinical trial data packages and regulatory documents
Domain
Pharmaceutical clinical development
Required skills
Clinical data review, Protocol deviation management, Case Report Form (CRF) development, Regulatory document writing, Pharmacovigilance support, Statistical analysis methodology, Therapeutic area expertise, Data collection and reporting, Data trend detection, Clinical study planning
Preferred skills
Rave system experience, OC-RDC experience, Learning design, Risk monitoring
Technologies
EDC systems, Excel, Rave, OC-RDC
Responsibilities
Perform patient-level clinical data review and trend analysis; Contribute to Data Review/Quality Plan development; Support CRF development and data capture tools; Facilitate data review process improvements; Review/write clinical trial documents for CSR and publications; Support pharmacovigilance activities; Produce training materials and present at study meetings
Seniority
Junior, hands-on IC