Clinical Data Manager (m/f/d)

Employment Type: Full-time, Fixed-Term Contract (24 months)

Your Responsibilities

• End-to-End Data Management: Lead core CDM activities, including the preparation of Data Management Plans (DMP), data cleaning, query management, SAE reconciliation, and Data Transfer Specifications (DTS).
• eCRF Design & Testing: Design and build Electronic Case Report Forms (eCRF) using major EDC systems (such as Medidata Rave, Veeva EDC, or Marvin) and execute User Acceptance Testing (UAT).
• Validation & Programming: Program and maintain data validation checks and edit checks utilizing SAS (preferred) or R to support data validation, analysis, and reporting.
• CDISC Standards & Quality Control: Perform database QC activities and produce CDISC-compliant documentation (e.g., Annotated CRFs, Define.xml files, and Reviewer’s Guides) aligned with SDTM and ADaM standards.
• Vendor & External Data Integration: Collaborate closely with CROs and external data providers to ensure smooth data transfers and seamless database integration.

Your Profile

• Education: Bachelor’s or Master’s degree in Life Sciences, Medical Informatics, Data Science, or a related field.
• Professional Experience: 2 to 4 years of proven experience in Clinical Data Management (eCRF development, data cleaning, and clinical trial data review).
• Technical Skills: Proficiency with leading EDC platforms and programming expertise in SAS (ideal) and/or R for edit check programming and data validation.
• Standards & Compliance: Solid working knowledge of CDISC standards (SDTM and ADaM) and the preparation of regulatory submission-ready datasets.
• Mindset & Communication: Detail-oriented, quality-driven analytical approach with fluent professional English skills.