岗位职责：

Leadership, Direction, and Strategy:

•Works with the Associate Director or Manager, External Data Delivery to ensure the quality and integrity of all in-bound data transfers and coordinates the timely delivery of all external data in line with the established data transfer agreements.

•Participates in Study Team meetings to provide file transmission status as needed.

•Proactively identifies risks to external file quality issues and/or data structure issues that could affect timelines for assigned studies and communicates issues to the Manager or AD, External Data Delivery.

•Assists in compiling information requested during internal and external audits.

•Participates in projects and teams contributing to the continual improvement of BDM processes and technologies.

Project Management:

•Manages assigned study quality deliverables for the timely acquisition and processing of external data in accordance with Daiichi Sankyo GSOP/GSOI, External File Transfer Specifications, and Electronic Data Transfer Specifications.

•Adjusts file delivery schedules to meet the Study and Data Acceptance processing needs.

•Maintains inspection readiness of documents generated during data transfer, receipt, and processing in partnership with DS partners and the Study Data Managers.

•Proactively identifies and works in conjunction with the AD or Manager, External Data Delivery in the resolution of issues that may influence and/or impact study quality, timelines, and other deliverables.

•Manages assignments to ensure deliverables meet study team expectations regarding quality and time.

Functional Expertise:

•Supports the acquisition and integration of external data.

•Ensures that the external file is stored in restricted folder when required by blinding and data protection requirements, performs a quality review, informs the AD or Manager, External Data Delivery of the findings and helps to identify appropriate actions to be taken.

•Tracks the acceptance of the processed external data into the appropriate Clinical Data Repository folder for the clinical study team to use.

•Works with the Manager, External Data Delivery to reject files with significant issues and follow up with the Study Data Managers to ensure that they have the information necessary to resolve the issues with the external vendor.

•Contributes to improving the foundational capabilities for the acquisition and processing of external data and helps to establish supporting processes and tools.

•Logs data receipts, to ensure traceability, data integrity verification, and improve visibility of datasets collected from various sources for each study and partners with the Study Data Managers to ensure logs/receipts are filed/archived according to applicable Daiichi Sankyo GSOP/GSOI.

•Adheres to appropriate work procedures/guidance, logs, templates, and quality procedures to achieve consistency and transparency across programs.

Operational Efficiency / Continuous Improvement:

•Provides external data file acquisition and processing expertise to ensure data is received and processed according to study timelines.

•Identifies opportunities to streamline processes in order to maintain or increase quality shorten receipt timelines of external study data.

资历要求：

•Experience in supporting and handling external data; viewing data in multiple formats including SAS

Skills:

•Work collaboratively with people at different levels of experience, different disciplines, and cultures

•Able to work independently; accepts guidance

•Strong communication, negotiation, and conflict resolution skills

•Ability to manage multiple priorities

•Strong background in Clinical Programming, Project Management, or data acquisition methods

•Proficient in industry standards for file management and security and clinical trial methodologies

•Willingness to learn