Mitarbeiter Betreuung klinische Studien (m/w/d)
Core
Support clinical studies and drug approval projects within the Medical Chemistry department for PET diagnostic precursors.
Role type
Clinical Study Support Specialist (Regulatory & Project Management)
Builds
Clinical study documentation, regulatory submission dossiers, and quality management records.
Domain
Pharmaceutical industry, PET diagnostics, Clinical Trials, Regulatory Affairs
Deliverable
client delivery
Required skills
Project management, Clinical study coordination, Regulatory compliance knowledge, Document creation and review, Statistical analysis, English (written and spoken), Office software (Word, Excel)
Preferred skills
Experience as a Monitor, Drug approval experience
Responsibilities
Organize and support clinical studies, Collaborate with external CROs and partners, Create and review study-specific documents, Monitor compliance with clinical trial regulations, Organize drug approval projects, Manage internal quality management documentation, Conduct research and document results, Organize conferences
Seniority
Mid-level, hands-on IC
