Promote standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency.
Support establishment of sound CDM processes including SOPs to ensure the highest data quality/integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
Provide program oversight for CDM activities including CRF/eCRF design, validation programming, discrepancy management, and database development and production.
Ensure studies are executed on time, within budget, and in adherence to quality standards.
Champion and lead the development and implementation of policies, standards, and process improvement initiatives.
Ensure CROs, suppliers, and internal staff meet the highest quality standards per SOPs.
Provide oversight and guidance, as well as establishing key performance metrics with CROs to ensure the highest data quality/integrity and regulatory compliance.
Responsible for vendor and technology (e.g., EDC or IRT) evaluation, qualification, and selection.
Use scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution.
Support strategic decision-making processes involving data management issues for ongoing clinical trials.
Promote productive collaboration between Biometrics & Digital Science and other functions (e.g., Biomarker, Clinical Operations, Clinical Science, Regulatory Affairs, QA, and IT) and ensure proper alignment around data management results.
Identify and implement solutions to global data management and EDC issues and concerns.
Provide strong leadership and inspiration to CDM staff. Recruit, develop, and motivate robust talents.
Work with the head of CDM for resource planning and budget forecasting. Provide input into budget, timelines, and resource needs for CDM with sound judgment and efficiency.
