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Associate Director, Business Planning

hace 3 meses

Barcelona, Barcelona, España AstraZeneca A tiempo completo

Job Description / Capsule


The AD, Procedural & Documentation Management for both Early & Late Data Management plays a key role in promoting and branding Data Management.

Ensures the efficiency of business operations and creates and implements changes or improvements as needed.

Plans and leads the strategy for process simplification and harmonization and ensures this is communicated across stakeholders and end users.

Serves as the expert in Clinical Data Management Process development to provide oversight and advice to the SMEs regarding the CDM Governing documentation development and maintenance

Monitor regulatory, technical and pharma-industry trends to implement continuous process improvements.

This position is responsible for one of the four components that supports Business Operations and will collaborate with the other three Associate Directors to strengthen the infrastructure of DM

Typical Accountabilities

  • Accountable for the update of processes to ensure that DM deliverables can be met in a harmonized, simplified manner while remaining compliant with HA guidelines and ensuring quality
  • Develops strategies for effectively communicating process changes internally and externally.
  • Able to bring a six sigma approach to process to ensure best practices are being upheld
  • Evaluate and improve business processes. Brainstorm and collaborate with teams for new ideas to enhance processes
  • In close collaboration with Business Process Management, continue to monitor and assess processes to ensure they are producing the desired outcomes
  • Liaises with counterparts in Process and Enablement to ensure that company SOPs are updated as necessary
  • Develop and produce highquality, informative, and interesting communications that brand DM
  • Ensure all messaging aligns with key business strategies
  • Develop content for social media, newsletters, town halls and any other distribution channels
  • Produces videos to detail who we are and what we do.
  • Develop reports that showcase activities in Data Management
  • Develop questionnaires that allow us to get feedback from stakeholders and baseline our business
  • Collaborates closely with crossfunctional colleagues (e.g. in SM&M, Study Management, Programming) to understand and ensure connectivity and dependencies of DM processes on other functional processes are thoroughly considered when providing SME input or working with PES to update processes.


 ECMS
  • Leads, facilitates, supports work in the tool
  • SOP steward and trainer
  • Manages and coordinates the assignment of resources for the review cycles of CBDM, CDM and Clinical Operations owned governing documentation and determines the appropriate CDM SME involvement in the review of such documentation. Interacts with LSI, Clinical Directors and CBDM Directors in this capacity.
  • Represents and serves as the SME for CDM during activities associated with all aspects of the LSI governing documentation system (AZDoc & AZLearn).
  • Partners with colleagues in AZ Learning, Standards & Insights (LSI) to ensure appropriate training curriculum is in place for DM staff
  • Translates business opbjectives into individual assignments and/or tasks
  • Collaborate and communicate with CBDM, Clinical Operations and partner CRO organizations to ensure coordination, compliance and proper use of DM Processes in data standards, database builds, programming and/or reports in clinical studies.
  • Leads the creation of the workstreams for developing new CDM governing documentation and supporting documentation
  • Provides oversight and advice to the workstream regarding the activities of creating SOPs, Guidelines, Job Aids and supporting templates and forms
  • Provide expertise and consultancy to TA Leads on interpretation of CDM governing documentation to ensure overall CDM quality and consistency.

Education, Qualifications, Skills and Experience

Essential

  • Bachelor in marketing, journalism, business, IT or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus
  • At least 5 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
  • Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.
  • Excellent organizational and analytical skills
  • Strong technical and problemsolving skills with experience on computer systems for Data Management.
  • Excellent understanding of clinical trial methodology, GCP, ICH, GCDMP and medical terminology
  • Experience with technologies and best practices across multiple platforms
  • Demonstrated experience to support complex projects and crossfunctional teams including delivering to project and portfolio metrics
  • Excellent communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress
  • Strong track record of building success