| Senior Data Analyst Clinical Operations at Remote, Remote, USA |
| Email: [email protected] |
| From: madhavan, AI Spins INC, [email protected] Reply to: [email protected] Job Title: Senior Data Analyst Clinical Operations Department: Global R&D Digital, Data & Informatics Qualifications, Experience and Skills Minimum Qualifications: Bachelors or higher degree in a scientific discipline (e.g., computer science/information systems, engineering, mathematics, natural sciences, medical, or biomedical science) or role-related, relevant work experience Professional Experience: At least 8-10 years of experience, with 5+ years of experience working in or supporting Clinical Operations/Data Management Proven knowledge of the business processes in Clinical Operations/Data Management Extensive experience/knowledge of technologies and trends including Visualizations /Advanced Analytics Outstanding analytical skills and result orientation Experience with business process development and gap analysis, and business process mapping efforts. Experience in working with software vendors for support and maintenance. Experience in working with RDBMS (e.g., SQL) and Reporting (e.g., Spotfire) Experience with GxP guidelines, Computer Software Validation (CSV), and SDLC Experience with Clinical Operational systems is highly preferred Additional Skills or Knowledge T echnical skills: Knowledgeable of systems in Clinical Operations domain Ability to understand complex functional requirements/requests from business users translate them into pragmatic and workable (technology) solutions. Familiar with Clinical Operations data, proven capabilities in supporting data analysis needs. Demonstrated success in supporting implementation projects of Clinical Operations solutions. Soft skills: Ability to work collaboratively with vendors and business clients to address business problems. Ability to work in a team of multidisciplinary scientists and IT personnel and operate effectively in a matrix environment; team player yet able to work independently. Strong written and verbal communications skills and the ability to interact with both technical and non-technical stakeholders and users. Ability to consider and manage change as a critical success factor for in-house systems. Demonstrated ability to prioritize work based on user need, business value, and return on investment Template Version Number: 01 Page 1 of 2 Position Summary and Job Responsibilities Job/Position Summary: Liaise with Clinical Operations to understand business needs and identify solutions that align to overall business strategies. Review, analyze and evaluate business systems and user needs. Job Responsibilities: Represent DDI as the Data analyst and technical SME in the Clinical business functional areas. Document Data Transfer Agreements for Data Exchange between Client and Data Providers (CRO, Partner Organizations) Document Data Transformation logic and interact with development team to convert business logic into technical details. Partner with Clinical to understand business needs and identify solutions that align to overall business strategies. Review, analyze and evaluate business systems and user needs. Responsible for business systems consulting, planning, prioritization, and implementation of deliverables, including implementations and operations. Develop process documentation (current and to-be). Document system, functional and business requirements, and objectives for Clinical initiatives. Technical SME for system activities for the clinical system(s), enhancements, and integration projects. Coordinates support activities across vendor(s). Systems include but are not limited to eTMF, EDC, CTMS and Analytics. Support in Identification and Implementation of new Clinical solutions. Interfaces with external vendors at all levels to manage the relationship and ensure the proper delivery of services. Identify and troubleshoot operational issues and system issues. Coordinate with Service team to provide oversight of vendor operational/maintenance and SLAs. Collaborate with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts. Support in GxP Computer System Validation activities for DDI, including implementation, validation, maintenance. Responsible for computer system validation and change control documentation including - System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (IQ/OQ/PQ/UAT), Traceability Matrix, Validation Summary Report. Support and maintain procedures and operational support processes for Quality Systems. Keywords: artificial intelligence rlang information technology Senior Data Analyst Clinical Operations [email protected] |
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| Mon Apr 01 21:10:00 UTC 2024 |