Description
Clinical Data Manager (6 months contract)Our client, a drug discovery and development company focused on developing therapeutic antibodies is currently searching for a Clinical Data Manager for a 6 month contract in the Geneva area.
Your tasks:
- Databases setup, testing, maintenance and data entry
- Clinical data management activities within clinical projects, including:
- Study documents review (SAP, specific sections of the study protocol, etc.)
- Development of the data management plan/CRF/eCRF and other data management guidelines/conventions
- Implementation of User Acceptance Tests (UATs), and Edit Checks
- Data Validation activities:
- Automatic and manual data inspections
- Data discrepancies/deficiencies review and resolution
- Query generation and resolution
- Feedback to the clinical trial team regarding quality of data
- Participation in data review meetings
- Ensure data system compliance by following guidelines of international regulatory authorities and internal policies
Your qualifications:
- Minimum 3 years of data management experience and working with clinical database applications
- Knowledge of SAS (programming) and CDISC
- Able to manage external providers
- Understanding of the research environment and good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11
- Ability to prioritize multiple tasks and manage time efficiently
- Fluent in French and in English
- Swiss resident or EU national
You can expect a challenging and responsible position. As Clinical Data Manager you will be part of a team and provide Clinical Data Management support to the Clinical Research Department in all phases of projects related to clinical development programs.
If this role is of interest to you, please send your CV in Word format including your hourly rate expectation for immediate consideration. You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: Clinical Data Manager, SAS, CDISC, Switzerland, French, English