Job Summary

The Associate Director, Clinical Data Warehouse is a member of the Biostatistics and Data Management team and serves as a subject matter expert in server technologies and manages operational activities and procedures to support Data Management operational business needs. The scope of work includes ownership and management of the BDM server, automation of data delivery, and dashboards for Clinical Data Management and study operations. The individual will also provide guidance and expertise on industry best practices applied to data management, study teams, and other stakeholders in the use of technology, data standards, and processes. This individual will help to improve quality by delivering enhanced business capabilities and efficiencies. This position will manage all EDC system integration activities to support internal and cross-functional business needs in conformance with applicable GxP requirements, global regulations, and data privacy laws. In addition, the individual will also engage in EDC administrative and operational improvements, provide oversight, contribute to the integration design specifications, and manage functional and user acceptance testing and risk management. This position will work closely with other members of the Biostatistics and Data Management teams, DS Information Technology, External CRO Partners, Functional Service Providers, Technology Providers, and other stakeholders. The primary location for this position is France, with Germany as the secondary location. 

Responsibilities

Leadership, Direction, and Strategy:

• Lead the development and implementation of the BDM server, solutions, operational improvements, and services strategy for the department.
• Lead initiatives with cross-functional impact and operational support.
• Manage direct reports, including the development, coaching, and mentoring of team members, as applicable.
• Contribute to the overall clinical systems strategy, roadmap, future plans, and infrastructure development.
• Engage with the Systems committee to assess and/or implement any changes required for improved efficiency, compliance, and operations.
• Foster strong and productive working relationships with key internal and external stakeholders, advance business objectives, and drive results.
• Participate in audits and regulatory inspections to provide program-level information as needed.
• Mentor, oversee, and train new team members.
• Promote Daiichi Sankyo values and a quality workplace culture, collaborate in cross-functional and multicultural settings, and build and maintain positive relationships with internal/external stakeholders/vendors/partners.

Project Management:

• Manage tactical and operational tasks and deliverables to achieve and deliver high-quality clinical databases for all studies.
• Manage the automation framework for validation and data delivery.
• Manage the Visualization framework that supports clinical decision-making and enables AI-driven initiatives in Oncology trials.
• Maintain inspection readiness of the procedural documents, associated forms, and trackers in accordance with the GSOP/GSOIs in partnership with project and study data managers, CRO partners, and functional service providers.
• Develop scalable solutions for data harmonization, metadata management, and interoperability across platforms.

Responsibilities Continued

Functional Expertise:

• Serve as a subject matter expert in developing dashboards to support oversight, guidance, and technical support in the planning, coordination, and delivery of high quality clinical study databases.  
• Lead EDC operational improvement initiatives anchored around process, technology, and quality to address potential gaps, improve efficiencies and productivity, and execute to completion in a timely manner.
• Establish appropriate SOP/SOIs, work procedures/guidance, database development templates, logs, quality procedures, risk & impact assessment and mitigation procedures, to maintain audit readiness, data integrity, security, consistency and transparency across studies.
• Establish a robust, scalable, and reliable reporting infrastructure strategy that enables the generation of on-demand and scheduled operational reports for downstream consumption.
• Lead content preparations and follow-up actions related to internal audits, and health authority inspections.
• Engage, initiate, and drive to resolution any issues pertaining to the functioning of the EDC system, process, and quality that impact the study and the timelines in collaboration with the technology providers and CRO partners, as necessary.
• Lead and coordinate the implementation of system patches, upgrades, and maintenance activities with internal and external stakeholders.
• Engage in the assessment, evaluation, and implementation of enhanced functional capabilities of current system technologies and/or new clinical system technologies of interest for R&D.
• Develop, coach, and mentor team members; support and implement individual development plans; and seek out training and growth opportunities.

Operational Efficiency /  Continuous Improvement:

• Identify opportunities for continuous process, technology, and quality improvements.
• Proactively identify risks and mitigation approaches to overcome project impediments and improve operational efficiencies.
• Establish metrics to help determine the efficiency, quality, and consistency across areas of study database build, post-production changes, and user access management among others. 
• Identifies and engages in process automation initiatives for improved efficiencies, quality, and productivity.  

Qualifications