| Lead Clinical Data Manager at Remote, Remote, USA |
| Email: [email protected] |
| Lead Clinical Data Manager Remote 12 Years Platform Manager - Responsibilities Lead projects from requirements definition through deployment, identifying schedules, scopes, and implementation plans, including risk mitigation Lead the team to define test strategies for projects, devising Installation Qualification, Operational Qualification, System Readiness Testing, Standard Operating Procedures (SOPs) and perform Change Management with validation quality control process Interface effectively with system business owners, quality, and vendors Establish and maintain relationships with relevant client stakeholders, providing day-to-day contact on project status and changes Arrange regular project governance meeting for assigned projects Arrange and manage Project Meetings and Walkthroughs Assign and monitor resources to ensure project efficiency and maximize deliverables. Report project outcomes and/or risks to the appropriate management channels and escalate issues, as necessary, according to project work plan. Manage Security and compliance of Regulated Systems Stay current with US and international regulations, industry standards, and emerging topics pertaining to GxP Computerized Systems, Computer Systems Validation and Data Integrity Collaborate with study team members and vendors to resolve data-related issues and discrepancies as part of data transfer agreement (DTA) Evaluate source-to-target mappings and information-model specification documents for datasets Create best-practice reports based on data mining, analysis, and visualizations Develop and maintain mapping queries by acquiring data from external data sources Skills/Experience Strong knowledge in Clinical trial and data management Knowledge of clinical and operational study data to understand the business requirements Experience in system documentation to draft requirement specifications In-depth knowledge of Clinical Data Standards like SDTM, ADaM, CDASH etc. Experience in Clinical data analytics platforms. Preferred SaaS system elluminate Vamshi B -- Keywords: information technology Lead Clinical Data Manager [email protected] |
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| Thu Oct 24 01:53:00 UTC 2024 |