Availability: Dependent on length and scope of project
Main Expertise
Clinical Data Management
Location and Availability
Denmark
Contact us
For more details on individual profiles and their availability please email kubosourcing@crosnt.com
Tel: +44 (0) 1908 488787
Profile #1101679
Profile #1101679
Key Skills
- IRT / IWRS / ePRO operations, validation, qualification
- Balance, Medidata
- eCaselink 8.0 IWRS, DSG
- Oracle IRT
- IBM Clinical Development
- IXRS3
- Clinical trial supply management
- GCP (patient randomisation, drug dispensing)
- GDP (drug product, prim. / sec. packaging and logistics)
Experience
- 10+ years’ experience within the pharmaceutical industry
- IRT / IWRS and ePRO systems (operational handling, validation and qualification)
- IRT / IWRS system coordination (system set-up, cUAT)
- Design of strategy and standards for IRT / IWRS and ePRO alignment with EDC and CTMS
- Implementation of an EDC system integrated with IRT / IWRS and ePRO (web based) together with associated departments and SaaS vendor
- Clinical trial supply chain coordination and operational management
- Deviation and CAPA management
- CMC production planning and forecasting
- Process optimisation (update / provision of SOP frameworks and implementation of local procedures, principles and systems to processes)
- IRT / IWRS: Balance, Medidata (systems user), eCaselink 8.0 IWRS, DSG (build), Oracle IRT (systems user), IBM Clinical Development (systems user), IXRS3 (systems user)
- EDC: Balance, Medidata (system user), DSG eCaselink 8.0 (certified designer), Oracle Health Sciences Inform
Education
- MSc Pharmacy / Medicinal Chemistry
- BSc Pharmacy