Job Summary

The Associate Director, External Data Acquisition and Processing (EDAP) is a member of the Biostatistics and Data Management (BDM) team and will provide strategic oversight and operational leadership for Daiichi Sankyo’s clinical trial portfolio, ensuring readiness of external data collection platforms, data conformance tools, and the delivery of high-quality, compliant external data from third-party vendors.  The individual will also support business critical operations for maintenance of the Clinical Data Repository (CDR) by being a subject matter expert in the use and management of the CDR. Engage and collaborate with DSI Information Technology, CRO Partners, and other internal and external stakeholders to ensure data acquisition deliverables are being met with quality and on time. The individual will provide guidance and expertise on industry best practices with respect to external data and Clinical Data Repository topics as applied to data management, study teams, and other stakeholders in the use of the technology, data standards, and processes to improve quality and deliver enhanced business capabilities and efficiencies. This position will work closely with other members of the BDM teams, external CRO Partners, and other stakeholders.

Responsibilities

Leadership, Direction, and Strategy:

• Oversee the execution of external data receipt and processing activities to ensure complete, high-quality external data is processed and available in a timely manner for all studies.
• Actively participates in day-to-day operations of systems setup, maintenance, configurations and related matters as a technical SME including providing managerial oversight of Business Administrators as well as can be counted as the backup to the Business Administrator.
• Lead external data acquisition, integration, quality oversight and delivery for all external data types and ensure vendor transfers and deliverables follow protocol, ICH, GCP guidelines and GSOPs.
• Leads in development and implementation of standardized operating procedures, process improvements and other CDR initiatives
• Proactively identifies and manages risks to data quality, data integrity, and timelines with respect to regulatory submissions. 
• Performs line management duties (provides feedback, conducts formal reviews, confirms training completion, and assists with career growth) for direct reports; functions as a mentor to staff
• Functions as the escalation point for all issues involving all activities performed by the EDAP team for all programs and users; proactively develops solutions within and across functions and resolves complex issues.

Project Management:

• Participate in technology implementation, enablement and/or maintenance related initiatives pertaining to external data transfers by providing business support to the DSI Information Technology and vendor teams whenever required.
• Partner with cross-functional stakeholders for the timely and quality transfer of external data as established in the data transfer agreement.
• Ensures that documents generated during EDAP activities follow applicable Daiichi Sankyo GSOP/GSOI to ensure inspection readiness.
• Plans and monitors team resources to maintain quality and timelines are met regarding external data acquisition and User Access maintenance.
• Provide leadership role in the oversight of external clinical data integration process including the overall strategy for acquisition and transfer of data from/to various third-party providers as contracted by DSI.

Responsibilities Continued

Functional Expertise:

• Supports cross-functional initiatives including process improvement, systems optimization, integrations including overseeing reported issues with Clinical Data Repository system.
• Participates in external vendor meetings to discuss future implementations, system upgrades, or enhancements that would allow DSI to maintain a competitive position within the industry by increasing quality and decreasing timelines within the BDM team.
• Supports the acquisition, ingestion and export of clinical data from various external third-party sources to enhance CDR efficiencies and quality of data transfer processes.
• Drive continuous process improvement activities aimed at maximizing efficiencies and improving overall quality of deliverables through lessons learned, industry trends, and experiences.
• Contributes to improving the foundational capabilities for the acquisition and processing of external data including establishing supporting processes and tools.
• Improves the review and coordination of the data transfer agreements with our partners for end-to-end improved quality, consistency, and integrity for all studies.
• Establishes appropriate operating framework for ways of working including procedures, data transfer logs, etc. to achieve consistency and transparency across programs.
• Contributes to the development, maturity, and consistent use of system centric external data standards across DS clinical programs.

Operational Efficiency / Continuous Improvement:

• Identifies opportunities for continuous process and technology improvements, defining and implementing the changes for improved quality, integrity, and compliance.
• Establishes metrics to help determine the efficiency, quality, and consistency of non-CRF data transfers through study close-out.
• Provides leadership within the Biostatistics and Data Management team by partnering with internal and external stakeholders to optimize existing technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).
• Evaluate emerging technologies, automation, and industry best practices by being current on industry trends, data standards, and other clinical technologies to improve importance for cancer enterprise operational efficiencies.
• Partner with DSI Information Technology and other stakeholders in the end-to-end implementation of technology solutions for BDM to deliver enhanced business capabilities and efficiencies.

Qualifications

Education Qualifications
Bachelor's Degree or equivalent experience. required

Experience Qualifications
7 or More Years in the bio-pharmaceutical industry with strong understanding and expertise in areas of clinical data storage, data management processes, data standards, technology, and quality. Expertise in best practices of external data acquisition, integration, and management; Knowledge of industry standard clinical technologies including, EDC, Clinical Data Repository, Reporting tools; knowledge and understanding of data acquisition and integration tools and technologies. Required

• Expertise in clinical data repository (CDR) management, clinical trial data storage and retention, and study blinding requirements
• Proficiency with known CDR systems like Sycamore, eClinical elluminate or similar
• Experience in handling and processing external data and programming tools like: SAS, J Review or similar
• Strong background in all Clinical Programming, Project Management, and data transfer methods
• Knowledge of data acquisition, ingestion and analytics  
• Expertise in supporting and handling external data; viewing data in multiple formats including SAS
• Knowledge of industry standards for file management, data security and clinical trial methodologies
• Strong knowledge and experience in computer systems validation, 21-CFR-Part11 compliance, drug development, and GxP required 
• Strong knowledge of industry standard clinical technologies including CTMS, eTMF, IRT