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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 .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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
Tailor your resumeApplicant 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