Team Lead SDTM (Biologist) | Biologe (m/w/d)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Nordrhein-Westfalen, Deutschland
Published Mar 23, 2026
Full-time
No information

Job Summary

This role involves leading and managing the SDTM (Study Data Tabulation Model) team for a renowned international contract research organization specializing in metabolic diseases. As a Team Lead, you will provide both technical and disciplinary leadership to a team in Germany and potentially other international locations. Your daily responsibilities will include resource planning, task allocation, and overseeing the progress of international clinical research projects. You will be responsible for interpreting CDISC guidelines, developing internal mapping standards, and ensuring high-quality deliverables across all projects. A key part of this role is fostering innovation, such as exploring AI applications and digitalizing SDTM processes. This position is ideal for a professional with a background in biology or life sciences who enjoys a mix of people management, technical data standards, and strategic process improvement within a regulated clinical environment.

Required Skills

Education

University degree in Natural Sciences (e.g., Biology or related field)

Experience

  • Several years of professional experience in clinical data management and SDTM
  • Experience in early clinical study phases (Phase 1/2) within a regulated environment (GCP, ICH)
  • Proven leadership experience with a focus on team and process development
  • Experience in process and decision-making responsibility for CDISC-compliant data structures
  • Experience in international project environments and cross-departmental coordination

Languages

German (Fluent)English (Fluent)

Additional

  • Willingness to participate in audits and inspections; responsibility for digitalization and AI technology application in SDTM processes; ability to manage international projects.