External Data Acquisition and Management-上海

该职位来源于猎聘 岗位职责： Leadership, Direction, and Strategy:

• Establishes and manages accountability for 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.
• Is an ambassador and Subject Matter Expert (SME) for all groups with a need to access external data.
• Participates in audits and inspections as the external data transfer SME for the study as needed.
• Participates in vendor audits as needed to illustrate and explain the file receipt, acceptance, logging, and documentation of incoming files to show compliance with regulatory requirements.
• Participates in Study Team meetings as needed to provide input and expertise on Electronic File Transmission Specifications (eDTS/EFTS).
• Assists in the development or modification of standard operating procedures, standard operating instructions, and job descriptions.
• Mentors, oversees, and trains Lead Associate / Associate team members in the proper acceptance testing, processing, and reconciliation of incoming data.
• Participates in projects and teams contributing to the continual improvement of BDM processes and technologies. Project Management:
• Manages all quality deliverables for the timely acquisition and processing of external data in accordance with Daiichi Sankyo GSOP/GSOI, External Data Transfer Plan (EDTP), and Electronic Data Transfer Specifications (eDTS).
• Maintains inspection readiness of documents generated during data transfer, receipt, processing, and reconciliation in partnership with DS partners and the Study Data Managers.
• Ensures effective quality oversight on the deliverables from CRO Partners and Functional Service Providers engaged in the acquisition, transmittal, and processing of external clinical data.
• Proactively identifies and assists in the resolution of issues that may influence and/or impact study quality, timelines, and other deliverables.
• Works closely with study teams to develop specifications, support ad-hoc external data reporting and reconciliation needs, and manage quality expectations in partnership with internal and external stakeholders.
• Ensures deliverables meet study team expectations regarding quality and time. Functional Expertise:
• Serves as an external data acquisition, integration, and reconciliation subject matter expert and provides oversight, technical, and hands-on support of the planning, setup, acquisition, integration, and reconciliation 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 Study Data Managers of the findings so that they may take appropriate actions.
• Tracks the acceptance of the processed external data into the appropriate Clinical Data Repository folder for the clinical study team to use.
• Rejects files with significant issues and follows 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 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 and 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 PDMs to ensure logs/receipts are filed/archived according to applicable Daiichi Sankyo GSOP/GSOI.
• Establishes appropriate work procedures/guidance, logs, templates, quality procedures, risk mitigation procedures, and achieves consistency and transparency across programs.
• Implements quality-by-design approaches to confirm the quality, integrity, and fitness-for-use of the external data based on appropriate and/or established data-cut-off as a pre-requisite for database lock. External Data Reconciliation:
• Designs, develops, and oversees external data reconciliation plans and specifications to compare and reconcile data received from multiple external sources (e.g., central labs, vendors, partner EDC, disease registries) against each other and against the Clinical Data Repository, to detect discrepancies, duplicates, and missing records.
• Performs and leads external data reconciliation using advanced SAS programming (BASE SAS, SAS MACRO, PROC SQL, PROC COMPARE, and hash objects) to automate comparison of large datasets across studies and vendors.
• Investigates and resolves reconciliation discrepancies, documents root causes, and drives corrective and preventive actions (CAPA) with external vendors and internal study teams.
• Establishes and maintains a library of validated, reusable SAS reconciliation macros/tools to standardize and streamline cross-source reconciliation, improving efficiency, consistency, and audit readiness.
• Reports reconciliation metrics (e.g., discrepancy rates, resolution turnaround time) to study teams and management to support data quality oversight through study close-out.
• Contributes to the development, maturity, and consistent use of external data standards across DS clinical programs.
• Participates in the development of and ensures compliance to SOPs, policies, work procedures, external data oversight plan, and guidelines. 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 and reconciliation through study close-out.
• Develops SAS macros / open-source tools to increase efficiency of data acquisition, processing, and reconciliation.
• Supports preparations and follow-up actions related to internal audits and health authority inspections. 资历要求：
• Bachelor's Degree or higher in life sciences or related field is required
• Minimum of 5 years of Global Clinical Trial Experience in the device/pharmaceutical/CRO industry; expertise in best practices of external data acquisition, integration, and management; knowledge of industry standard clinical technologies including CTMS, EDC, Clinical Data Repository; knowledge of CDASH and CDISC data standards; knowledge and understanding of data acquisition and integration tools and technologies.
• Of these, a minimum of 5 years of hands-on clinical statistical programming experience using SAS in China-based global clinical trials is required (see Computer level for detail).
• Work collaboratively with people at different levels of experience, different disciplines, and cultures
• Self-directed; able to work independently
• Strong communication, negotiation, and conflict resolution skills
• Ability to manage multiple priorities
• Strong background in Clinical Programming, Project Management, and data acquisition methods
• Proficient in industry standards for file management and security and clinical trial methodologies
• Knowledge of data comparison methods and data integrity algorithms
• Expertise in supporting and handling external data; viewing data in multiple formats including SAS
• Advanced SAS programming capability (see Computer level) with the ability to design, validate, and maintain reusable programs/macros for external data acquisition, processing, and reconciliation
• Fluent oral and written English is required
• SAS Programming (key technical requirement):
• Minimum of 5 years of hands-on clinical statistical programming experience using SAS in China-based global clinical trials (pharmaceutical/CRO), at a level equivalent to a mid-to-senior clinical programmer.
• Expert-level proficiency in BASE SAS, SAS MACRO, PROC SQL, PROC COMPARE, PROC REPORT, and SAS/STAT; able to write efficient, well-documented, and reproducible programs processing datasets of 1,000,000+ records across 10+ studies.
• Demonstrated ability to design, develop, validate, and maintain a library of 20+ reusable, validated SAS macros/utilities for external data acquisition, processing, and cross-source reconciliation, following macro validation and documentation standards aligned with company SOP and regulatory/CDISC expectations.
• Proficient in applying CDISC standards (SDTM, ADaM) and using tools such as Pinnacle 21 / define.xml to verify data structure, metadata, and traceability; able to translate data transfer specifications (eDTS/EFTS) into executable SAS reconciliation and validation programs.
• Solid understanding of data comparison methodologies and data integrity algorithms (e.g., record-level key matching, hash-object joins, fuzzy matching) to automate reconciliation between disparate external sources and the Clinical Data Repository.
• Familiar with SAS on Windows/Linux and batch automation, and with integrating EDC (e.g., Medidata RAVE), central lab, and vendor data; working knowledge of at least one scripting language (e.g., Python, R, or shell) to complement SAS automation is a plus.