17 ago
|
AstraZeneca
|
Barcelona
17 ago
AstraZeneca
Barcelona
Experteer Overview
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In this role you will lead and promote Data Management processes and documentation to ensure efficient operations and compliance. You will drive process simplification, harmonization, and governance across DM, collaborating with SMEs and cross-functional teams. You will develop clear communications, training, and materials to brand DM internally and externally, while guiding CDM governing documentation. This is a strategic position focused on improving processes, enabling regulatory compliance, and supporting data management initiatives at scale.
Compensaciones / Ventajas
• Review and update DM processes for harmonization and GxP-compliant delivery
• Develop and communicate process changes to internal and external stakeholders
• Apply Six Sigma principles to optimize processes
• Collaborate with PM/Process Enablement to update SOPs as needed
• Create high-quality communications, reports, and content to brand DM
• Produce material for social channels, newsletters, town halls, and videos
• Coordinate DM process-related workstreams and governance documentation
• Lead stakeholder engagement and DM SME involvement in documentation reviews
• Manage resources for governance documentation reviews across Biometrics, DM, and Clinical Operations
• Represent DM in LSI documentation systems (AZDoc u0026 AZLearn) and ensure training curricula
• Translate business objectives into assignable tasks for DM staff
• Coordinate with Biometrics, DM, Clinical Operations and CROs to ensure DM process alignment with data standards and programming
• Shape new CDM governance documentation workstreams and supporting documents
• Provide expert input on SOPs, Guidelines, Job Aids, and templates
• Advise TA Leads on CDM governance interpretation to ensure quality and consistency
Responsabilidades
• Bachelor in scientific discipline or related field; advanced degree a plus
• Pharmaceutical/biotech/CRO/Regulatory experience
• Project management experience xqbhyrx with DM initiatives
• Ability to work independently under tight deadlines
• Excellent organizational and analytical skills
• Strong technical and problem-solving skills with data management systems
• Solid understanding of clinical trials, GCP, ICH, GCDMP, and medical terminology
• Experience with cross-platform technologies and best practices
• Track record of leading complex, cross-functional projects and delivering metrics
• Excellent communication and negotiation skills; strong stakeholder management
• Strategic thinking with business analytics ability to translate needs into requirements
• Strong team player
Requisitos principales
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📌 Associate Director, Process & Documentation, Clinial Data Management (Barcelona)
🏢 AstraZeneca
📍 Barcelona