
yana smuts
clinical operations leader
About
Clinical Operations Leader with more than 11 years of experience in phase II-IV clinical trial studies in various indications, working in CROs and in a Pharmaceutical Company. Broad background in clinical trials management and very extensive monitoring experience, including coordination and performing in-house / onsite monitoring activities, collecting / submitting regulatory documentation, performing feasibility, qualification, initiation, monitoring and termination of investigational-sites. Problem solving attitude, taking initiative and working independently with strong communication and leadership skills, leading European global team members, effectively communicating with internal and external customers as well as third party vendors.
canada
dartmouth
pharmaceuticals
clinical monitoring, ich gcp, gcp, cro, clinical trials, ctms, therapeutic areas, clinical development, pharmacovigilance, clinical research, infectious diseases, pharmaceutical industry
Experience

owner
caphe viet

clinical operations leader
parexel

senior clinical research associate
parexel

senior cra and project manager
onq research
General acceptable CRA requirements - Site maintenance and monitoring of clinical trial conduct in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines, and any other applicable requirements to ensure full compliance. Reporting on site visits, safety events and study progress to all relevant parties. Monitoring/SDV and Data clearing of CRFs and study documents for data processing. Managing and Maintaining all local Study Files.

cra
onq research

cra
parexel

ca and cra
iqvia

cra
astrazeneca r&d

associate clinical operations leader
parexel
Education
university of pretoria/universiteit van pretoria
yana smuts's Contact Information
Phone
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