Director, Clinical Data Management

at  AstraZeneca

TYPICAL ACCOUNTABILITIES

Establish asset level strategies to ensure consistency, efficiency, and excellence in the application of CDM standards, implementing advanced predictive data monitoring practices and knowledge sharing within a TA.

• Execute the CDM Leadership strategy for the relevant TA or processes, ensuring alignment with the vision, principles, and strategy of partnering teams i.e., Dev Ops Biometrics Data Operations, TA-wide or process business strategy. Full decision-making responsibility for all aspects of CDM execution at the TA indication.

o Capacity Management and Alignment for DM: Ensure appropriate resources are available (internal and/or external) and assigned appropriately to meet demand of CDM function

o Manage relationships with internal and external partners to ensure the CDM strategy is appropriate in the wider context i.e., TA Directors, Training and Risk Management, Quality Management, Statistics and Programming, Study Management Teams, Digital Health, external vendors.

• Ensure clinical trial data provided for exploratory or reporting purposes are high integrity, high quality, timely and fit for purpose to meet the needs of the Clinical organization
• Serves as the expert in Clinical Data Management to provide oversight and advice to all staff within the function regarding process around DM deliverables and compliance
• Accountable for development and maintenance of vendor relationships and contracts, maintaining strong relationships to enable fit for purpose delivery of clinical trial data in line with established agreements.
• Establish and monitor relevant indicators of group performance; use these to continuously improve clinical data management services. Evaluates resource gaps and create headcount requests and justification.
• Accountable for assessing quality gaps and CAPA submissions, determining isolated events from systemic issues and developing improved process mitigation strategies and trainings.
• Partner with Standards Group and Study Management colleagues to support portfolio and TA level data standards to enable the right balance of efficiency, flexibility and value in how data is handled and used
• Accountable for driving team performance and authority to assign work to staff in more than one country in CDM. Serves as an escalation point to direct reports and/or Data Managers leading studies within their assigned TA/indication
• Attract, develop, and retain top talent; provide direction, real time situational mentoring, career development guidance. Actively work to promote team building and positive culture within the department.
• May act as designee of the Senior Director where appropriate

Please refer the Job description for details