Description
We are looking for a
Clinical Data Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Ticino
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Work within the R&D Biostats and Data Management team
- Coordinate and supervise the activities of defining the CRF (Case Report Form) in accordance with Sponsor CRF Library, Data Validation Plan, Data Management Plan (generally outsourced to CROs)
- In case of electronic CRF or electronic Diary (eCRF / eDiary) test its functionalities
- Review all the Data Management documents (e.g. Data Management Plan and Data Validation Plan)
- Coordinate and participate in the activities of Computer System integration and test its functionalities (e.g. IWRS and eCRF; eDiary and eCRF)
- Participate in defining the raw data dataset structure (SDTM) and coordinating activities with CRO data management
- Review the collected clinical data throughout the conduct of the study in order to ensure that data cleaning activities are carried out consistently and thoroughly
- Participate in the Blind Data Review Meeting
Your qualifications
- Knowledge of English language is essential
- Knowledge of Italian language is of advantage
- Knowledge of SAS system and of CDISC Standards is essential
- Team working skills
- Profound experience as Clinical Data Manager
Skills:
- Clinical data manager