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Ividata Life Sciences

Lead Data Manager, Consultant

Ividata Life Sciences

. Provide oversight and leadership for CDISC SDTM programming across a portfolio of 5 to 10 clinical studies in all phases, particularly in Oncology and Neuroscience .

Posted 10/6/2026full-timeParis • FranceSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in CDISC SDTM programming and SAS programming, with a strong focus on data management and regulatory compliance in clinical studies, particularly in Oncology and Neuroscience. Proven ability to oversee projects, manage subcontractors, and ensure high-quality deliverables within defined timelines.

Highest-signal resume keywords
CDISC SDTM ProgrammingSAS ProgrammingClinical Data ManagementRegulatory Compliance (GCP, ICH)Vendor Management (CRO Oversight)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
SAS ProgrammingCDISC SDTM FormatData StructuringQuality Control (QC)Regulatory Documentation (Define.xml, sDRG)Data TransformationAutomated ProgrammingClinical Database ArchitectureGood Data Management PracticesOncology and Neuroscience Knowledge
Soft Skills
Organizational SkillsAttention to DetailAnalytical SkillsProblem-Solving SkillsAutonomy
Industry Keywords
Clinical StudiesBiostatisticsBioinformaticsData ManagementPharmaceuticalBiotechnology

About the role

Key responsibilities & impact
  • Provide oversight and leadership for CDISC SDTM programming across a portfolio of 5 to 10 clinical studies in all phases, particularly in Oncology and Neuroscience
  • Coordinate SDTM dataset programming activities performed by subcontractors
  • Ensure deliverable quality and adherence to deadlines
  • Perform quality control (QC) of SDTM databases and ensure compliance
  • Contribute to the creation and review of regulatory documentation, including specifications, sDRG, and Define.xml
  • Develop and maintain automated SAS programs for data transformation and derivation
  • Manage the transfer and sharing of databases with external partners as part of clinical studies
  • Ensure the proper application of CDISC standards, Good Data Management Practices, and applicable regulatory requirements
  • Collaborate with pharmaceutical and biotechnology clients on high-value projects

Requirements

What you’ll need
  • Education: Master’s degree / five-year higher education degree in Biostatistics, Bioinformatics, Data Management, or an equivalent scientific field
  • At least 5 years of experience in clinical Data Management with CDISC programming
  • Advanced proficiency in SAS programming
  • Strong command of data structuring in the CDISC-SDTM format
  • Excellent knowledge of information systems, clinical database architecture, and related documentation (Define.xml, sDRG)
  • Proficiency in applicable regulatory requirements (GCP/Good Clinical Practice, ICH guidelines, and CDISC standards)
  • Experience managing and overseeing vendors/subcontractors (CRO oversight)
  • Knowledge of the Oncology and/or Neuroscience therapeutic areas is preferred
  • Autonomy, rigor, strong organizational skills, and attention to detail
  • Strong analytical and problem-solving skills
  • Ability to coordinate multiple projects and manage priorities in line with defined deadlines
  • Professional written and spoken English required for international collaboration and documentation

Benefits

Comp & perks
  • A stimulating, collaborative, and constantly evolving environment
  • High-impact assignments
  • Hybrid working arrangement with the possibility of remote work
  • Opportunity to work alongside passionate experts
  • A genuine opportunity to make an impact through your ideas and expertise
  • Work on projects across diverse Life Sciences sectors