Senior Business Analyst

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)