Senior Manager, Global Clinical Scientist - Psychiatry
Core
Design and execute clinical trial activities and programs for psychiatry, serving as a scientific expert to ensure study quality and regulatory compliance.
Role type
Senior Manager, Global Clinical Scientist (Clinical Operations)
Builds
Clinical trials and associated regulatory documentation for pharmaceutical products
Domain
Life Sciences / Psychiatry / Clinical Research
Required skills
GCP/ICH knowledge, study design, protocol development, medical writing, data trend analysis, project management, regulatory document contribution
Preferred skills
Life Sciences degree (MD, PhD, Pharm D, MS, RN), experience with data monitoring committees, familiarity with disease area and clinical landscape
Technologies
Microsoft Word, Excel, PowerPoint, data review tools (Pt Profiles)
Responsibilities
Develop protocol and ICF documents, conduct literature reviews, review clinical narratives, monitor clinical data for trends, develop data review plans, submit clinical contributions to study reports and regulatory documents, liaise with external partners (KOLs), lead or support trial-level activities
Seniority
Senior Manager, hands-on IC with leadership responsibilities
