
Organized and dependable Senior Study Manager successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Intentional problem-solver with strong attention to detail.
Language Capabilities English
CTMS, Ecrf, IVRS databases
Strong leadership skills and proactive work ethics
Medical and research terminology
Federal and global regulations, good clinical practices (GCP), HIPPA
Strong organizational skillsEffective written and verbal communication skillsFDA and Sponsor Audit Readiness
Balance tasks with competing priorities
Critical thinker and problem solverTraining Study protocols
Trial management
Central/Local IRB
Regulatory Compliance
Vault CDMS Certification
Vault CDMS Certification
Florence IQVIA Certification
GCP-ICH Certification
ACRP Ethics and Human Subject Protection Certification
ACRP Inspection Readiness