Clinical Data Manager – 7130

Clinical Data Manager – 7130

Our client is seeking a hands-on Data Manager to support Clinical Data Management activities. The role requires immediate contribution to Data Management Plan preparation, Data Cleaning, Query Management, SAE Reconciliation, and Data Transfer Specifications

The start date is asap for a 24 month-contract based in Basel area .

Main Responsibilities:

• Clinical Data Management activities, including Data Management Plan preparation, Data Cleaning, Query Management, SAE Reconciliation, and Data Transfer Specifications
• Electronic Case Report Form (eCRF) Design and Development using EDC system such as Medidata Rave, Veeva EDC, Marvin
• Programming and maintenance of data validation checks
• Creation of CDISC-compliant documentation, including Annotated CRFs, Define.xml files, and Reviewer’s Guides
• Ensure Data Management activities comply with internal standards and regulatory requirements
• Support the development and testing of (e)CRFs and data review tools
• Contribute to the creation of Data Management documentation
• Perform data review, discrepancy and query management, and protocol deviation tracking
• Archive study documentation in accordance with guidelines

Qualifications and Experience:

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• A Bachelor’s degree or higher in a pharmaceutical or biomedical discipline (e.g., Biological Sciences, Pharmacology)
• Minimum 2-4 years of experience in Clinical Research or Clinical Data Management within the Pharmaceutical or Biotech industry
• Knowledgeable in CDISC SDTM and ADaM standards, with programming skills in SAS and/or R to support data validation, data analysis, and reporting activities.
• Familiar with clinical data management processes, vendor data integration, and the preparation of submission-ready documentation.
• Working knowledge of CDISC standards (SDTM and ADaM)
• SAS and or R Programming (ideally SAS)
• User Acceptance Testing (UAT)
• Database Quality Control activities
• Collaboration with CROs and external data providers
• Fluent in English