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Accenture Federal Services, a division of Accenture, provides technology and consulting services to U.S. federal agencies, delivering solutions that enhance per
Lead Clinical Data Manager
Location
Pennsylvania + 1 moreAll locations: Pennsylvania | New Jersey
Posted
61 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Lead Clinical Data Manager
Accenture
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• Responsible for acquiring, processing, and reviewing patient data • Organizing clinical data forms, implementing data management plans • Data management POC for DMTI and clinical studies • Develop, implement, and conduct data quality checks as needed for work/studies • Ensure collection, organization, curation, storage and safeguarding of patient data • Track emerging study data and works closely with data science team • Responsible for maintaining, updating, and organizing data transfer specifications across studies
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• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices. • Independently serves as the lead point of contact for all data management study-related communications. • Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports. • Reviews and assists in the development of study documents drafted by CROs such as Data Management Plans, Data Validation Specifications, eCRF Completion Guidelines, Data Review Plans, Data Transfer Agreements, and other cross-functional study documents that may require data management input. • Ensures the quality of clinical data within the EDC and other databases through regular data review and external data reconciliation processes and communicates any outstanding issues to the cross-functional teams. • Monitors and tracks the quality of all data management deliverables. • Leads data deliverables including snapshots for DMC, investor relations, publications, etc., and interim and final database locks, in collaboration with the CRO DM Vendor. • Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines. • Leads and facilitates Data Review Meetings with the cross-functional team, presenting metrics, trends, risks, and or issues. • Actively participates in team meetings – DM or cross-functional. • Coordinates transfers of SAS datasets or external data transfers from CROs. • Support TFL reviews, yearly regulatory submission requirements, compilation of CSRs, etc. • Responsible for TMF maintenance of data management-related study documents. • Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
- Leading the architecture, design, strategy, development and implementation of agentic AI systems capable of goal-driven decision-making, planning, and action under real-world constraints - Translate product and customer requirements into production grade AI system designs - Drive rapid iteration of deployment while maintaining system reliability and safety - Participating in peer-reviews of solution designs and related code - Working with teammates to dive efβiciencies to development procedures - Analyzing and resolving technical problems - Deβining standards for the platform to deliver AI solutions - Balance learning-based approaches with deterministic or rules-based components where appropriate - Support customer-facing and sales technical discussions when AI and platform expertise is required
• Design and implement data validation pipelines and model evaluation workflows in a cloud environment (AWS). • Integrate data and evaluation metrics into an automated, auditable pipeline. • Modularize the pipeline to facilitate reuse, testing, and maintenance. • Collaborate with Data Science, Data Engineering, and Product teams. • Ensure best practices for versioning, logging, monitoring, and automated testing. • Propose continuous improvements to data architecture and validation processes.


