Data Manager
Il y a 1 jour
Brussels, Brussels-Capital, Belgique
Akkodis
Temps plein
Gratuit avec email ou Google
Enregistrez cette offre et organisez votre recherche
Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.
Gratuit avec email ou Google
En continuant, vous acceptez nos Conditions d’utilisation & Politique de confidentialité.
About Akkodis
Akkodis is a global engineering and technology consulting company supporting organizations in the development, transformation and optimization of their products, systems, and operations. Our experts work across engineering, digital and software, Data & AI, manufacturing, and life sciences, contributing to projects in sectors such as mobility, aerospace, energy, and healthcare. At Akkodis, you join an international environment where you can develop your expertise, work on challenging projects and build a career that evolves with your ambitions.
Your Responsibilities
• Lead and coordinate CDISC SDTM programming activities across multiple clinical studies within a global clinical development environment.
• Oversee external programming partners and ensure the timely delivery of high-quality SDTM datasets.
• Perform quality control reviews of SDTM datasets and associated documentation to ensure compliance with CDISC standards and regulatory requirements.
• Develop, review and maintain SDTM programming outputs using SAS.
• Participate in the preparation and validation of regulatory deliverables including SDTM specifications, SDRG and Define.xml documentation.
• Ensure clinical data transformations are performed according to CDISC standards and internal data management processes.
• Manage clinical data transfers and data sharing activities with external partners and stakeholders.
• Collaborate closely with Clinical Data Management, Biostatistics, Statistical Programming and Clinical Operations teams.
• Monitor project timelines, deliverables and risks across several studies simultaneously.
• Identify data quality issues, perform root cause analyses and drive remediation activities.
• Contribute to process improvement initiatives related to clinical data standards, data quality and regulatory readiness.
• Support studies across various clinical development phases within complex therapeutic areas.
Your Profile
• Bachelor's or Master's degree in Life Sciences, Biostatistics, Data Management, Computer Science or a related discipline.
• 5 to 10 years of experience in Clinical Data Management, Clinical Programming or a related function.
• Strong expertise in CDISC standards, particularly SDTM.
• Significant hands-on experience with SAS programming in a clinical research environment.
• Solid understanding of GCP, ICH guidelines, regulatory submission requirements and Clinical Data Management best practices.
• Experience reviewing and validating SDTM datasets, specifications and regulatory documentation.
• Good understanding of clinical databases, data structures and data transformation processes.
• Experience coordinating external vendors or CROs is highly appreciated.
• Strong project coordination skills and ability to manage multiple studies and priorities simultaneously.
• Analytical mindset with excellent problem-solving capabilities.
• Detail-oriented, autonomous and highly organized.
• Strong commitment to quality, compliance and continuous improvement.
• Excellent communication and stakeholder management skills.
• Fluent in English. Practical details
Location:
Belgium. Hybrid working model. Long-term mission within an international life sciences environment. Start date: ASAP. What we have to offer At Akkodis, we want to give you the right environment to develop your expertise and grow throughout your career. You can count on:
• A permanent contract
• An attractive compensation package, including 13.92 months of salary
• A company car or mobility budget, depending on your package
• A flexible cafeteria plan
• Hospitalization insurance
• Training and development opportunities to strengthen both your technical and professional skills
• A structured onboarding and regular follow-up, including career discussions and support from your managers
• Access to technical communities and experts to exchange knowledge and develop your expertise
• Referral and business bonuses when you contribute to growing our teams and business
• Opportunities to develop your career across different projects, technologies, and areas of expertise
• Lead and coordinate CDISC SDTM programming activities across multiple clinical studies within a global clinical development environment.
• Oversee external programming partners and ensure the timely delivery of high-quality SDTM datasets.
• Perform quality control reviews of SDTM datasets and associated documentation to ensure compliance with CDISC standards and regulatory requirements.
• Develop, review and maintain SDTM programming outputs using SAS.
• Participate in the preparation and validation of regulatory deliverables including SDTM specifications, SDRG and Define.xml documentation.
• Ensure clinical data transformations are performed according to CDISC standards and internal data management processes.
• Manage clinical data transfers and data sharing activities with external partners and stakeholders.
• Collaborate closely with Clinical Data Management, Biostatistics, Statistical Programming and Clinical Operations teams.
• Monitor project timelines, deliverables and risks across several studies simultaneously.
• Identify data quality issues, perform root cause analyses and drive remediation activities.
• Contribute to process improvement initiatives related to clinical data standards, data quality and regulatory readiness.
• Support studies across various clinical development phases within complex therapeutic areas.
Your Profile
• Bachelor's or Master's degree in Life Sciences, Biostatistics, Data Management, Computer Science or a related discipline.
• 5 to 10 years of experience in Clinical Data Management, Clinical Programming or a related function.
• Strong expertise in CDISC standards, particularly SDTM.
• Significant hands-on experience with SAS programming in a clinical research environment.
• Solid understanding of GCP, ICH guidelines, regulatory submission requirements and Clinical Data Management best practices.
• Experience reviewing and validating SDTM datasets, specifications and regulatory documentation.
• Good understanding of clinical databases, data structures and data transformation processes.
• Experience coordinating external vendors or CROs is highly appreciated.
• Strong project coordination skills and ability to manage multiple studies and priorities simultaneously.
• Analytical mindset with excellent problem-solving capabilities.
• Detail-oriented, autonomous and highly organized.
• Strong commitment to quality, compliance and continuous improvement.
• Excellent communication and stakeholder management skills.
• Fluent in English. Practical details
Location:
Belgium. Hybrid working model. Long-term mission within an international life sciences environment. Start date: ASAP. What we have to offer At Akkodis, we want to give you the right environment to develop your expertise and grow throughout your career. You can count on:
• A permanent contract
• An attractive compensation package, including 13.92 months of salary
• A company car or mobility budget, depending on your package
• A flexible cafeteria plan
• Hospitalization insurance
• Training and development opportunities to strengthen both your technical and professional skills
• A structured onboarding and regular follow-up, including career discussions and support from your managers
• Access to technical communities and experts to exchange knowledge and develop your expertise
• Referral and business bonuses when you contribute to growing our teams and business
• Opportunities to develop your career across different projects, technologies, and areas of expertise