Senior Business Analyst
Primary Location: Poland, Remote Additional Locations: Romania, Remote; Serbia, Remote Job ID R0000036496 Category AdministrativeAbout this Role
The Senior Business Analyst will work closely with the business and technical teams, to elicit, refine and document requirements (ex. Functional requirements, user stories and specifications) in a manner that both reflects the true need of the business, and holistically and comprehensively outlines the solution need for IT leads, architects, and developers.
Within this role the candidate needs to possess knowledge of Good Practice (GxP) quality software validation processes. With a continuous improvement mindset, the Senior Business Analyst will look for opportunities to refine processes, tools, techniques and standards; creating efficiency within the Business Analysis process while delivering concise, complete and comprehensible requirements for features, functions, and behaviors of the needed solution(s).
Key Accountabilities:
Lead comprehensive analysis of business needs, processes, and workflows across clinical research functions
Conduct thorough requirements gathering sessions with stakeholders at all levels of the organization
Translate complex business needs into clear, detailed, and actionable requirements documentation
Develop use cases, user stories, and functional specifications that accurately reflect business requirements
Validate requirements with stakeholders to ensure completeness and accuracy
Prioritize requirements based on business value, technical feasibility, and strategic alignment
Identify dependencies, constraints, and assumptions that may impact solution implementation
Analyze current state business processes to identify inefficiencies, gaps, and improvement opportunities
Document existing workflows using process mapping techniques and industry-standard notation
Design future state processes that optimize efficiency, quality, and compliance
Develop recommendations for process standardization and automation
Perform cost-benefit analyses for proposed process changes and solutions
Lead process improvement initiatives across clinical operations functions
Measure and report on the effectiveness of implemented process changes
Collaborate with technical teams to design solutions that meet business requirements
Develop functional specifications and design documents for system implementations
Create detailed system configuration specifications for clinical application
Lead business analysis activities for medium to large-scale projects
Develop project scope, objectives, and deliverables related to business analysis
Create and manage business analysis work plans and timelines
Identify and manage risks related to requirements and solution implementation
Provide regular status updates on business analysis activities to project stakeholders
Build and maintain relationships with key stakeholders across clinical operations functions
Facilitate communication between business units and technology teams
Skills:
Analytical Skills
Advanced business process analysis and modeling techniques
Requirements elicitation, analysis, and management methodologies
Strong problem-solving and critical thinking abilities
Data analysis and interpretation capabilities
Process improvement and optimization approaches
Cost-benefit and impact analysis
Root cause analysis and solution development
Technical Skills
Proficiency with business analysis tools and software (JIRA, Confluence, Visio, etc.)
Experience with process modeling notations (BPMN, UML, flowcharts)
Understanding of database concepts and data modeling
Knowledge of clinical systems architecture and integration points
Familiarity with project management methodologies and tools
Ability to create detailed functional specifications and requirements documentation
Experience with requirements traceability and management tools
Communication Skills
Exceptional written and verbal communication
Advanced facilitation and workshop leadership
Presentation and executive communication capabilities
Technical writing and documentation skills
Stakeholder management and relationship building
Negotiation and conflict resolution
Ability to communicate complex concepts to diverse audiences
Leadership Skills
Team leadership and mentoring
Project planning and coordination
Decision-making and problem-solving
Change management and organizational readiness
Strategic thinking and business acumen
Influence without authority
Time management and prioritization
Knowledge and Experience:
5-7 years of business analysis experience, with experience in clinical research or pharmaceutical industry
Demonstrated experience leading requirements gathering and process improvement initiatives
Strong understanding of clinical trial processes and workflows
Experience with clinical systems implementation and configuration (EDC, CTMS, eTMF, etc.)
Knowledge of regulatory requirements in clinical research (GCP, ICH, FDA, EMA)
Experience with Agile and traditional software development methodologies
Background in implementing or optimizing clinical data management processes
Experience leading cross-functional teams and facilitating decision-making
Track record of successful process improvement or system implementation projects
Education:
Bachelor's degree in business administration, information systems, life sciences, or related field
Training in process improvement methodologies (Lean, Six Sigma)
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