
Core Interests
Developing Areas of Interest
Pharmacist with expertise in clinical pharmacology, pharmacovigilance, and clinical trial management. Experienced in hospital and research settings, with skills in drug logistics, regulatory compliance, and data management. Passionate about innovative pharmaceutical technologies, AI applications in pharmacology, and personalized therapies. In details, CRC/ data manager at the Cardiothoracic department for the management of observational studies and and clinical trials (phases II–IV) according to ICH-GCP standards and company SOPs. Skills in
- coordination of clinical studies, from start-up to closure
- Collection, management, and validation of clinical data; compilation and monitoring of eCRFs via electronic platforms (e.g., Medidata Rave, RedCap)
- Management of relationships with stakeholders such as clinical trial centers, sponsors, PIs, monitors/CRAs, ethics committees, and hospital pharmacies
- Management of the investigational drug product (IMP) and any NIMPs/PeIMPs (logistics, storage, and accountability, pharmacovigilance)
- Supervision of study procedures, protocol compliance, and preparation for audits and inspections (including SIV, MoV, COV)
- Maintenance and updating of the Investigator Site File and archiving of regulatory documentation
Skills and Achievements:
ability in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and some software like wth Wingesfar, Fed80, WebDPC, and EUSIS systems