Experteer Overview
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As Associate Director, Process u0026amp; Documentation for Data Management, you lead process simplification and harmonization to improve DM efficiency while ensuring GxP and regulatory compliance. You will shape and communicate DM processes across functions and externally, partnering with SMEs to govern CDM documentation. Your role drives continuous improvement through Six Sigma principles, cross-functional collaboration, and engaging internal and CRO partners. This position offers a chance to brand DM activities, enhance data standards, and influence study-level data management outcomes. You will operate in a matrix environment, aligning DM strategy with AZ’s broader objectives and industry trends.
Compensaciones / Incentivos
• Review and update DM processes for harmonization and compliance with HA guidelines
• Develop and communicate strategies for process changes internally and externally
• Apply Six Sigma approaches to improve processes and ensure best practices
• Collaborate with cross-functional teams to ensure connectivity of DM with other processes
• Create high-quality communications (social media, newsletters, town halls) and brand DM
• Lead DM governing documentation workstreams and CDM SOPs/G Guidelines
• Coordinate resources for documentation review cycles and determine SME involvement




• Provide expertise on interpretation of CDM governing documentation to TA Leads and PES
• Represent DM in LSI governing documentation system activities (AZDoc u0026 AZLearn)
• Collaborate with Biometrics, Data Management, Clinical Operations and CROs to ensure coordination and compliance in data standards and reports
• Oversee training curricula development with LSI for DM staff
• Translate business objectives into actionable assignments and tasks
• Lead creation of workstreams for new CDM governing documentation and templates
• Monitor regulatory and industry trends to drive process improvements
Responsabilidades
• Bachelor in scientific discipline; advanced degree a plus
• Experience xqbhyrx in pharmaceutical, biotech, CRO or regulatory agency environments
• Project management experience with DM SMEs on special initiatives
• Ability to work independently under pressure with tight deadlines
• Strong organizational and analytical skills
• Excellent technical and problem-solving abilities with data management systems
• Solid understanding of clinical trial methodology, GCP, ICH, GCDMP and medical terminology
• Experience with multiple platforms and data management technologies
• Proven ability to drive complex projects with cross-functional teams and metrics
• Excellent communication, interpersonal and negotiation skills
Requisitos principales
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📌 Associate Director, Process & Documentation, Clinial Data Management (Barcelona)
🏢 AstraZeneca
📍 Barcelona