Senior Technical Business Analyst – Clinical Study Design and Analysis

TheSeniorTechnicalBusiness Analystdrives technology initiatives and projectswithend-to-end accountability fordelivering business value. This roleleveragesdomain and business processexpertiseto detail product requirements as epics and user stories, along with supporting artifacts like business process maps,use cases,and testplansfor the software development teams.This role involves working closely with developers, testers,andbusinessteamsto ensure that thetechnical requirements for upcoming development are thoroughly elaborated. Thisenablesthe delivery team to estimate, plan, and commit to delivery with high confidenceandidentifytest cases and scenariosto ensure the quality and performance of ITsystems.This rolewill collaborate withproductmanagers,other business analysts, system administrators, testers,developers, andbusiness stakeholders with high technical literacy tomaintainan efficient and consistent delivery process focused on quality, compliance, and business continuity.

Roles & Responsibilities:

• EnableandevolveClinical Study Design and Analysisfunctionalcapabilities throughdelivery oftechnology implementations and projects

• Apply independent judgment and decision-making to define scope, drive alignment, and ensure outcomes are delivered

• Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals

• Capture the voice of the customer to define business processes and product needs

• Provide technical feasibility assessments in real-time during requirements elicitation

• Work with Product Managers and customers to define scope andbusinessvalue for new developments

• Collaborate with Engineeringon design specifications

• Collaborate withProductOwnersto prioritize release scopes andrefinetheproductand capabilitybacklogs

• Partner with business analysts in other regions todelegate project responsibilities based on timezone and access to relevant stakeholders

• Define project timelines and drive delivery of system implementations, enhancements, and release validationto meetthe communicated plans

• Ensure non-functional requirements are included and prioritized in theproduct andreleasebacklogs

• Facilitate the breakdown of Epics into Features andsprint-sized User Stories andparticipatein backlog reviews with the development team

• Clearly express features in User Stories/requirements so all team members and stakeholders understand howthey will be achieved

• Translate complex business and technological needs into clear, actionable, and testablerequirements for developmentand validationteams

• Ensure Acceptance Criteria are well-defined

• Work closely withSoftware-as-a-Service suppliers tomeet businessrequirementswith configuration, custom releases,androadmap prioritization

• Manage project timelines and deliverables toensuredelivery targets are metand stakeholders are informed of progress

• Develop and execute effective product demonstrations for internal and external stakeholders

• Participate in code and design reviews to ensurestandards andbest practices are followed

• Maintainaccuratedocumentation ofrequirements,configurations, processes, and changes

• Manage change control and documentation lifecyclesin strict adherence tostandard operating procedures (SOPs)

• Identifyand manage risks associated with the systems, including technological risks, validation, and user acceptance

• Bachelor’s degree with 6 - 8 years of experience ina Technical Business Analyst roleOR

• Diploma with 10 - 12 years of experience ina Technical Business Analyst role
  

Functional Skills:

Must-Have Skills:

• Writingcomprehensive functional and non-functionalrequirements for developmentand implementationofbusinessapplications in a GxP regulatedenvironment

• Project delivery followingAgile software development methodologies (Scrum)

• Excellent communication skills and the ability tointerface withsenior leadership with confidence and clarity

• Technical thought leadership and highly conversant in softwareengineering,systemarchitecture and integrations, and data sciencesterminology

Good-to-Have Skills:

• Excellent problem-solving skills and a passion for tackling complex challenges inclinical developmentwith technology

• Demonstratedexpertisein aclinical developmentdomain and related technology needs

• Understanding of biostatistical analysis methods

• Experience in managing product features for PI planning and developing product roadmaps and user journeys

• Familiarity with low-code, no-code test automation software

• Experience with thelatest generative AIcapabilities, includingbuildingagentic AIworkflowsand/or custom GPTs

• Able to communicate technical or complex subject matters in business terms

• Jira Align experience

• Knowledge of Databricks andAWScloud platforms

• Experience withSoftware-as-a-Serviceapplication implementationsand release management and validation

Professional Certifications:

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision

• Skilled in providing oversight and mentoring team members.Demonstratedabilityineffectively delegatingwork

• Excellent analytical and gap/fit assessment skills

• Strong verbal and written communication skills

• Ability to work effectively with global, virtual teams

• High degree of initiative and self-motivation

• Ability to manage multiple priorities successfully

• Team-oriented, with a focus on achieving team goals

• Strong presentation and public speaking skills

Shift Information:

This positionmayrequire you toworka later shift schedule. Candidates must be willing and able to work duringevening, asrequiredbased on business requirements.