Associate Director Project Data Manager

1 week ago

Mississauga, Ontario, Canada AstraZeneca Full time

Responsible for overseeing Clinical Data Management (CDM) delivery of high-quality data through external partners or internally run studies for assigned projects or indications. Alternatively, acts as an expert on CDM projects and technology beyond CDM program support. Stays updated on trends/changes in external CDM approaches and serves as a process development and improvement subject matter expert. Might lead a team or provide training to junior colleagues within CDM.

  • Provides CDM leadership for assigned projects, indications, or studies based on project size. Takes global accountability and acts as the second contact at the project level.
  • Demonstrates leadership and operational expertise in strategic planning and delivering CDM outcomes at the project level. Manages vendor contracts, resources, budgets, and vendor performance for assigned projects and studies.
  • Communicates and negotiates effectively with all project team members. Main CDM contact at the Global Program Team (GPT) level.
  • Demonstrates a business sense of the compound profile to identify and support the application of consistent CDM processes and documentation across assigned projects (ensuring data quality plan consistency).
  • Oversees and provides expertise on external service providers or in-house teams to deliver quality data complying with study model procedures and standards; offers guidance on AZ standards, processes, systems, and expectations to partners.
  • Responsible for proactive risk management and issue resolution/escalation related to CDM enhancement or technology.
  • Proactively suggests improvements to AZ Standards, CDM processes, and technologies. May also be an Expert in any of these fields.
  • Develops an understanding of CDASH and SDTM or other industry standards and their impact on programming teams to ensure program level standards' consistency.
  • Specializes in TA-specific data capture and standards, conducts lessons learned, and disseminates them across the organization as needed.
  • Offers data management expertise in supporting strategic and operational aspects of Data Management at the project level.
  • Might lead or mentor CDM colleagues and stakeholders with operational processes in studies and projects.
  • Represents CDM at cross-functional forums, meetings, and provides timely feedback to partners.
  • Understands health authority requirements and contributes to CDM-related activities associated with regulatory inspections/audits and liaison with Clinical Quality Assurance. May also assist with AZ QIs.
  • Shows willingness to lead any project level activity consistent with current experience in support of study delivery. May also act as a Study Data Manager for assigned studies.
  • Handles CDM-related ad-hoc requests from Line Manager. Supports Line Manager with portfolio oversight.

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AstraZeneca is a workplace where diversity and inclusion are highly valued, and all individuals are treated fairly, free from discrimination. The company also offers support for individuals with disabilities throughout the recruitment, assessment, and selection process, available upon request.

Date Posted

30-May-2024

Closing Date

01-Jul-2024

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