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Clinical Data Manager 80% (m/f/d) (EN)
[11628]
Clinical Data Management
Job title: Clinical Data Manager 80% (m/f/d) Industry: Pharma Skills: Clinical Data Management Start of project: 01.09.2022 Duration of the project : 12 months Location: Luzern, Switzerland Tasks: ·Setting up EDC in the system ·Designing the platform for studies ·Support on SOP development ·Maintenance in accordance with ISO standard ·Support preparation of the Study ·Co-ordinate and maintain the running of the registry which is an IBM system (real world data setup) ·Designing the IBM registry ·Data verification during clinical study execution ·Check compliance with clinical investigation plan ·Preparation of Data Management/Analysis report ·Close out of the Data Management System ·Experience in TMF (trial master file) control ·Experience Preparing the CRF (Case Report Form) in the system ·Testing the system Qualifications: ·Must know IBM system software ·1-3 years Data Management experience ·Life Science University Degree or equivalent ·English business level speaker/ fluent ·Must know EDC (Electronic Data Capture System) ·Must know CTMS (Clinical Trial Management System) ·Candidate must be located in Switzerland ·SPS programming ·Statistical programming Proportion on site: ·Posibility of working 50% home office We are looking for a candidate who is: ·A great team player with good team interaction ·Open minded ·High values of transparency ·Flexibility ·Good with deadlines and committed to the project
Skills: Clinical Data Management
- Setting up EDC in the system
- Designing the platform for studies
- Support on SOP development
- Maintenance in accordance with ISO standard
- Support preparation of the Study
- Co-ordinate and maintain the running of the registry which is an IBM system (real world data setup)
- Designing the IBM registry
- Data verification during clinical study execution
- Check compliance with clinical investigation plan
- Preparation of Data Management/Analysis report
- Close out of the Data Management System
- Experience in TMF (trial master file) control
- Experience Preparing the CRF (Case Report Form) in the system
- Testing the system
- Must know IBM system software
- 1-3 years Data Management experience
- Life Science University Degree or equivalent
- English business level speaker/ fluent
- Must know EDC (Electronic Data Capture System)
- Must know CTMS (Clinical Trial Management System)
- Candidate must be located in Switzerland
- SPS programming
- Statistical programming
- Posibility of working 50% home office
- A great team player with good team interaction
- Open minded
- High values of transparency
- Flexibility
- Good with deadlines and committed to the project
