пропозиції роботи
Sylwia Kondratiuk
Clinical Operations Enablement Specialist, AstraZeneca Pharma Poland Sp. z o.o.
Warszawa,
mazowieckie
Dołącz do GoldenLine i obejrzyj pełny profil tej użytkowniczki
Zobacz pełny profil
Języki
angielski
biegły
niemiecki
dobry
Doświadczenie zawodowe
Clinical Operations Enablement Associate
• Registration of clinical studies and disclosure of summarized Technical Results/CSR Synopsis on public websites
• Providing guidance to Study Teams regarding studies registration/results disclosure process and requirements of Clinicaltrails.gov Quality Assurance Team
• Receipt of Clinical Data and loading into repository CSRE/CAVE
• Ensuring consistency of clinical data according to Data Standards by performing comparison reports
• Providing guidance to Study Teams regarding studies registration/results disclosure process and requirements of Clinicaltrails.gov Quality Assurance Team
• Receipt of Clinical Data and loading into repository CSRE/CAVE
• Ensuring consistency of clinical data according to Data Standards by performing comparison reports
Assistant Clinical Data Coordinator
• Ensuring completeness, consistency and quality of clinical data
• Running data integrity check reports to identify missing and inconsistent data
• Addressing clinical data integrity issues to investigational site staff by raising queries and verifying site’s responses in accordance to study documents
• Coordination of Oncology Study as a Data Project Lead – Network communication with CRA, CS, DMS to resolve protocol issues, fix reports
• Performing Quality Control of reviewed data (DRQA): individual and global
• Running data integrity check reports to identify missing and inconsistent data
• Addressing clinical data integrity issues to investigational site staff by raising queries and verifying site’s responses in accordance to study documents
• Coordination of Oncology Study as a Data Project Lead – Network communication with CRA, CS, DMS to resolve protocol issues, fix reports
• Performing Quality Control of reviewed data (DRQA): individual and global
Intern in Quality Control
- Conducting quality control tests
- Supporting coordination of R&D tests on production
- Construction process maps
- Supporting coordination of R&D tests on production
- Construction process maps
Szkolenia i kursy
- Certification from EDC application for Global Data Operations - Inform System
- GCP - Internal Company Training
- Audits and Inspections Training - Internal Company Training
- Course ‘English for Biotechnology’ at University of Technology
- GCP - Internal Company Training
- Audits and Inspections Training - Internal Company Training
- Course ‘English for Biotechnology’ at University of Technology
Edukacja
Biotechnologia, magisterskie
Politechnika Warszawska
Specjalizacje
Badania i rozwój
Inne
Grupy
Politechnika Warszawska
Politechnika Warszawska jest najstarszą polską uczelnią techniczną. Od ponad 180 lat kształci kolejne pokolenia inżynierów, wnosząc istotny wkład w rozwój nauk technicznych.
