Senior Business Analyst

Accountabilities: Business analysis and requirements management: Lead comprehensive assessments of business needs, processes, and workflows across clinical research functions. Facilitate requirements-gathering sessions with stakeholders at different organizational levels and translate complex needs into clear, detailed, and actionable documentation. Requirements documentation and validation: Develop use cases, user stories, functional specifications, and solution documentation. Validate requirements with stakeholders to ensure accuracy, completeness, alignment with business objectives, and feasibility for implementation. Process analysis and optimization: Assess existing workflows to identify inefficiencies, operational gaps, and opportunities for improvement. Map current-state processes, design optimized future-state workflows, and recommend standardization or automation initiatives to improve productivity, quality, and compliance. Performance measurement and business cases: Conduct cost-benefit analyses for proposed process changes, establish appropriate performance measures, and monitor the effectiveness of implemented improvements to demonstrate business value. Solution design and system implementation: Collaborate with technical teams to translate business requirements into functional solutions and design documents. Support the implementation and configuration of clinical systems, ensuring solutions meet operational needs and applicable quality standards. Testing, validation, and end-user support: Contribute to test planning and execution by developing test plans and test cases, validating system functionality against business requirements, and identifying issues requiring resolution. Prepare training materials and supporting documentation to facilitate user adoption. Project coordination and risk management: Lead business analysis activities for medium- to large-scale projects, define scope and deliverables, manage analysis work plans and timelines, and identify and mitigate risks associated with requirements, implementation, and delivery. Stakeholder engagement and communication: Build productive relationships across clinical operations, business functions, and technology teams. Facilitate discussions, align stakeholders on priorities, and present findings, recommendations, and proposed solutions to audiences at different organizational levels. Leadership and continuous improvement: Mentor junior business analysts, share best practices, and support the development of team capabilities. Monitor emerging industry trends and regulatory changes to identify opportunities for innovation in clinical processes, systems, and operational delivery. Requirements: Professional experience: 5–7 years of business analysis experience, including at least 3 years in clinical research, the pharmaceutical industry, or a closely related regulated environment. Business analysis expertise: Demonstrated experience leading requirements gathering, documenting functional specifications, analyzing business processes, and delivering process improvement initiatives. Clinical research knowledge: Strong understanding of clinical trial processes and workflows, including the operational requirements and challenges associated with clinical development. Clinical systems experience: Practical experience with the implementation, configuration, or optimization of clinical research systems, such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Trial Master Files (eTMF). Regulatory knowledge: Familiarity with clinical research regulations, guidelines, and quality standards, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and relevant FDA and EMA requirements. Technical and analytical skills: Advanced analytical and problem-solving capabilities, with proficiency in business analysis tools such as JIRA, Confluence, and Microsoft Visio. Familiarity with process modeling techniques and notations, including BPMN, UML, and flowcharts, is expected. Methodologies: Experience working with Agile and traditional software development methodologies, with the ability to adapt business analysis practices to different project environments. Communication and facilitation: Excellent written and verbal communication skills, including the ability to facilitate stakeholder workshops, deliver presentations, and explain complex business and technical concepts to diverse audiences. Leadership and collaboration: Strong project coordination, decision-making, and stakeholder management skills, with the ability to influence without formal authority, manage competing priorities, and mentor colleagues. Attention to detail and quality: A patient-focused approach, commitment to regulatory compliance, and the ability to maintain high standards of accuracy, documentation, and operational quality. Educational qualifications: Bachelor's degree in business administration, information systems, life sciences, or a related discipline. Preferred certifications: Professional credentials such as Certified Business Analysis Professional (CBAP), other International Institute of Business Analysis (IIBA) certifications, or PMI Professional in Business Analysis (PMI-PBA). Additional advantages: Training or certification in Lean or Six Sigma methodologies, experience optimizing clinical data management processes, and a track record of leading cross-functional teams and facilitating complex business decisions. Benefits: Remote working arrangement: Work remotely from India, with opportunities to collaborate with a geographically distributed team. Full-time employment: Join a global clinical research environment focused on operational excellence and the advancement of healthcare. Meaningful impact: Contribute to improving clinical research processes that support the development of new therapies and better patient outcomes. Professional development: Expand your expertise across business analysis, clinical operations, regulatory compliance, and clinical technology implementation. Career growth opportunities: Explore different career paths across clinical research operations, business transformation, and technology integration. Collaborative environment: Work alongside cross-functional professionals and contribute to strategic initiatives that improve the quality and efficiency of clinical research. Leadership opportunities: Mentor junior colleagues, share expertise, and help strengthen business analysis practices and team capabilities. Continuous learning: Develop your skills through exposure to evolving clinical research technologies, regulatory requirements, and process improvement methodologies. Flexible work culture: Benefit from an environment that values flexibility, professional growth, and the ability to deliver meaningful results.