Clinical Operations Data Analyst

• Bachelor s 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
• 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
• 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

Technical 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
• 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

Position Summary and Job Responsibilities

• 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.
• 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
• 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
• Support and maintain procedures and operational support processes for Quality Systems.