Senior Clinical Scientist
Core
Senior Clinical Scientist providing medical and scientific support to the Clinical Research Director, managing clinical trial setup through study report completion in compliance with regulatory standards.
Role type
Senior Clinical Scientist (Study Medical Manager)
Builds
Clinical trials for rheumatology/immunology therapeutics
Domain
Biopharma / Rheumatology / Immunology
Deliverable
client delivery
Required skills
Clinical trial design and execution, protocol and informed consent form preparation, CRF design, data listing review and analysis, statistical report interpretation, regulatory strategy development, cross-functional collaboration, KOL and investigator relationship management, governance committee presentation
Preferred skills
Late-stage clinical development (Phase 2b/3), translational medicine and biomarkers knowledge, complex global project management, cross-functional team leadership, regulatory authority interaction
Technologies
None explicitly stated
Responsibilities
Support design and execution of multiple clinical studies, prepare key trial documents including protocols and consent forms, contribute to CRF design and review, review and analyze data listings and statistical reports, partner with data management to generate queries, deliver clinical landscape updates, build presentations for governance committees, serve as delegate for CRD in clinical development planning, act as liaison across data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs, and clinical operations, co-author briefing packages for health authority submissions, build and maintain relationships with internal collaborators, KOLs, and investigators
Seniority
Senior, hands-on IC
