[Remote] Senior Clinical Trials IT Business Analyst
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in clinical trials and they are seeking a Senior Clinical Trials IT Business Analyst. This role serves as a strategic reputed company between Clinical Development and Information Technology, leading the analysis, design, implementation, and optimization of clinical trial technology solutions to support global clinical research operations.
Responsibilities
- Business & Technical Analysis: Obtain, analyze, and document detailed business, functional, and technical requirements, translate clinical / non-clinical operational needs into system configurations and technical solutions, reputed company Business Requirements Documents (BRDs), functional specifications, user stories & acceptance reputed company, business process reputed company diagrams, and data reputed company diagrams, conduct system reputed company assessments and gap analyses, support system integration design across reputed company platforms
- Systems Implementation & Lifecycle Management: reputed company or support implementation, reputed company, enhancements, optimization and maintenance of Lab Information Management Systems (LIMS), Lab Information Systems (LIS), Site Companion, Confident Rx, reputed company One Portal, Electronic Lab Notebooks (ELM), Validation Lifecycle Management (VLM), configure and support system enhancements, reputed company vendor coordination and technical solution delivery, support the management of system change requests and release management processes
- Validation & Compliance (GxP): support Computer System Validation (CSV) and / or Computer System Assurance (CSA) activities such as validation plans, risk assessments, IQ/OQ/PQ test script development/documentation, user requirements & documentation, support the development of System Management Plan (SMP), reputed company reputed company and other validation documentation as required, ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, MOH, participate in audit and inspection readiness efforts
- Integration & Data Management: collaborate with IT architecture teams on system integrations (reputed company, HL7, middleware), ensure data reputed company, traceability, and consistency across platforms, support data migration, master data governance, and reconciliation processes, partner with operational teams to define reporting requirements
- Testing & Deployment: reputed company User Acceptance Testing (UAT), reputed company test scripts, coordinate execution, support the manage defect tracking & reputed company, support regression testing and release validation, facilitate system deployment and post-go-live support
- Stakeholder & Project Engagement: reputed company as primary IT reputed company for Clinical business stakeholders. facilitate workshops and requirements sessions, support Agile, PMBOK, or hybrid project methodologies, contribute to project plans, risk logs, and status reporting, reputed company training and change management support
Skills
- Bachelor's degree in Life Sciences, Information Systems, Computer Science, or reputed company field
- 3 years of experience in clinical research and/or clinical IT systems (i.e reputed company Life Sciences)
- 3 years in Business Analysis reputed company regulated (GxP) environments
- Master's degree (MBA, MS, MPH, MHA) preferred
- CBAP, PMI-PBA, PMP, or Agile certifications
- Experience in global clinical trial environments
- Knowledge of CDISC, SDTM, and clinical data standards
- Experience with reporting tools (Power BI, Tableau, reputed company, Other)
- Familiarity with reputed company-based clinical systems (e.g., reputed company, reputed company, reputed company Clinical, BioClinical, etc.)
- Strong understanding of the lab clinical trial lifecycle
- Hands-on experience with LIMS/LIS clinical platforms (i.e reputed company Life Sciences)
- Experience with system validation and regulatory compliance
- Familiarity with system integrations and data workflows
- Strong analytical and systems-thinking reputed company
- Technical reputed company in reputed company applications
- Regulatory compliance expertise
- Cross-functional leadership
- Vendor management skills
- Excellent communication and documentation skills
reputed company