Senior R&D Technologist - Quality Operations & Risk Management

What You'll Do

Client Engagement & Requirements Gathering

• Lead and participate in clinical business process discussions with clients to identify requirements and develop user stories

• Conduct interviews and workshops to gather requirements that support business needs

• Author high-level user stories with related tasks, acceptance criteria, and test case reviews

Business Analysis & Documentation

• Work as a business and data analyst on strategy, assessment, and technology implementation projects within clinical quality, operations, and risk-based quality management

• Create Requirement Specifications, Requirements Traceability Matrices (RTM), and other project documentation

• Perform business process modeling, data flow analysis, user experience modeling, and solution architecture diagramming

• Act as a techno-functional liaison between client business users and engineering teams to ensure accurate translation of business context and rules

Solution Design & Implementation

• Design and implement innovative solutions in risk-based quality management, clinical operations, and quality management

• Support technology implementations by bridging business requirements with technical delivery

• Contribute to building offerings from concept through prototype to full-scale implementation

Team Collaboration & Development

• Support the growth of the Business Analysis capability through mentoring junior colleagues

• Contribute to the development of the BA community within the practice

What You'll Bring

Education

• Bachelor's or Masters degree in Pharmacy, Bioinformatics, Medicine, or related disciplines (required)

Experience

• 3-6 years of experience within the Life Durg development Risk management or clinical trial management as business analyst, or data analyst

• Proven experience building solutions in drug development areas such as central monitoring, risk assessments, clinical operations, quality management, or data management

• Hands-on experience working in risk-based quality management or Clinical trial Operations as Analyst

• Understanding of end-to-end processes for clinical risk assessment and Clinical trial execution

• Exposure to clinical data coordination and clinical data management

Skills & Competencies

• Critical thinking and problem-solving skills with the ability to distill complex concepts into clear, actionable insights for clients

• Experience managing deliverables within large and complex programs

• Understanding of Agile methodologies and project lifecycle management

• Strong stakeholder management and communication skills

• Exposure to data modeling (preferred)