Medical Evidence Data Management Leader at AstraZeneca

Business Area: Medical Evidence studies include primary and secondary data collection studies, such as interventional and observational studies and Real World Evidence.

About the Role

The Medical Evidence Data Management Leader (MEDML) at AstraZeneca will oversee the delivery of high-quality data through external partners for assigned Medical Evidence studies. Responsibilities include supervision of communication, specifications, and documentation. The MEDML guarantees the overall quality and integrity of the database, ensuring data is collected and managed accurately and securely in line with study protocols and highest scientific industry standards. The MEDML serves as the core evidence team member for data management (DM) and data quality, acting as a subject matter expert in data management processes, projects, and technology.

Roles & Responsibilities

Management and Oversight:

• Supervise external partners
• Manage stakeholders' and collaborators' understanding and expectations of all aspects of MEDM
• Assess and manage overall DM vendor performance and delivery
• Ensure DM vendor complies with AstraZeneca (AZ) procedural requirements

Guidance and Supervision:

• Oversee completeness and quality of DM documentation
• Provide guidance to DM vendor representatives working on the study
• Resolve DM-related issues by developing solutions to complex problems

Timeline and Deliverable Management:

• Monitor DM timelines and deliverables
• Provide advice and oversight to the evidence team regarding DM activities

Data Quality and Integrity:

• Ensure quality and consistency with AZ data collection strategies and standards
• Serve as a Subject Matter Expert (SME) on DM processes and requirements

Regulatory Compliance and Inspections:

• Provide input to DM-related activities during regulatory inspections/audits
• Ensure alignment with health authority requirements

Process Improvement and Standards:

• Support the development and maintenance of DM processes and standards
• Facilitate valid changes to project standards

Requirements

Education: Minimum of a BS in life sciences or computer science. Experience may substitute for education.

Experience:

• Data Management experience in the Biotech/Pharma/CRO industry
• Understanding of GCP and regulatory requirements related to DM systems and activities
• Knowledge of Good Clinical Data Management Practices (GCDMP) and Real World Evidence landscape
• Experience with databases, clinical DM systems, and electronic data capture (EDC)

Skills:

• Strong communication and interpersonal skills
• Excellent written and verbal communication skills
• Effective problem-solving and conflict resolution skills
• Ability to work independently and in a global team environment
• High attention to detail and accuracy

Desirable Skills & Experience

• Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
• Knowledge of clinical and pharmaceutical drug development processes
• Understanding of database structures, data standards (CDISC), and practices
• Experience in clinical data system design/development/validation
• Ability to work effectively with external partners and interact at all management levels

Why Work With Us?

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture

Learn more about working with us in Canada or view our YouTube channel.

If you're interested in working at AstraZeneca,

AstraZeneca is an equal opportunity