This position is responsible for bridging the gap between business needs and technical solutions and plays a pivotal role in ensuring that the solutions developed and implemented by IT align with our business strategies, objectives and processes. The position requires people with a blend of technical, analytical and interpersonal skills and how to apply these in the Pharmaceutical Industry. They will need to understand how to work with both GxP and non-GxP systems and a good understanding of the Clinical (Drug) Development Lifecycle.
The Business Analyst will be involved throughout the project lifecycle from initial concept through to delivery and post implementation support. They will be responsible for facilitating communication between stakeholders and IT Professionals, ensuring that the solutions developed address business problems and add value. They will be directly responsible for requirements gathering and analysis, modelling business and IT processes, managing project scopes, solutions design, in scope testing and ongoing user and system support.
Responsibilities:
Requirements Gathering and Analysis: Collaborate with the business teams across R&D and Enterprise Operations to gather and analyze requirements for IT projects. Design, develop and document supporting business processes and translate these into functional and non-functional requirements or user stories.
Solution Design: Work with the Enterprise Architect and IT development team to design and/or specify technology solutions that meet business needs. Ensure that the solution can fintegrate with existing technology landscape and if required, complies with GxP (Good Practice) guidelines and regulatory requirements i.e FDA 21 CFR Part 11
Solution Delivery: Ensure that all IT solutions comply with internal standards and required regulatory requirements. Participate in the Computer Systems Validation (CSV) process including the creation and execution of test plans to ensure the compliance and efficacy of the system. For non GxP processes ensure compliance with SDLC process and produce deliverables where responsible.
Project Management Support: Assist the project manager or PMO in the planning, execution and monitoring of IT projects, ensuring they are delivered on time, within scope and budget. Work with the project manager and scrum person to ensure that the project can meet its required deadlines. Identify and project risks and issues, working with IT teams to propose mitigation strategies.
Stakeholder Communication and Management: Act as a liaison between IT and the business functions, ensuring clear communication and understanding of requirements, timelines and project statues. Facilitate and lead workshops to ensure alignment and consensus amongst the stakeholders.
System Maintenance and Continuous Improvement: Ensure that systems are maintained and updated post go live (where assigned) working closely with the business owner to ensure any enhancements or bug-fix issues are planned for and remediated. Recommend improvements to business processes and IT solutions, driving innovation and efficiency within the company. Suggest new and emerging technologies and trends in the pharmaceutical industry that could benefit the Institute.
Skills & Abilities:
- Superior communication (verbal and written) and presentation skills with the ability to effectively advocate technical solutions and results to technology and business audiences.
- Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities.
- Ability to work independently and collaboratively with cross-functional/inter-departmental teams and within the framework of the Enterprise Operations IT organization.
- Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able to deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation.
- Team-oriented and generous in sharing knowledge and enabling others.
- Strong communication and facilitation skills to lead teams to establish consensus, ensure clarity and decisions/justifications.
- Effective negotiation and persuasion skills to manage stakeholder expectations.
- Excellent time management and the ability to prioritize tasks effectively.
- Attention to detail in documenting requirements, creating reports, and managing project documentation.
- Creative and critical thinking skills to develop innovative solutions to business challenges.
Required Technical Knowledge/Experience/Skills:
- Strong understanding of agile concepts and certification in agile methodology
- Strong understanding of modern data systems and tools including data platforms, data warehouses, data lakes, data ingestion, distribution pipelines, and data analytics/visualization how to apply this knowledge to clinical and real-world data.
- Strong Pharma/Life Sciences experience with an in-depth understanding of Clinical Development and Operations processes
Strong understanding and working knowledge of:
- GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)
- Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML)
- Nonclinical Study Data (SEND)
- Safety Data (ISO/HL7 27953: E2B(r2), E2B(r3); ICSR, PADER, PSUR, DSUR)
- Experience working in a Computer System Validation (CSV) process and SDLC process.
Understanding and experience with Pharma related Technology Solutions/Platforms, including but not limited to:
- PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
- Strong understanding and experience designing solutions and working in and Azure and AWS Cloud Environments
- Understanding of software development processes and methodologies (e.g., Agile, Scrum, Waterfall, SDLC).
- Certified and experienced in working within an agile framework e.g. SaFe and as part of an agile team.
- Able to work within Jira and is proficient in creating and managing Epics, User Stories and Tasks.
- Able to analyze complex data to identify trends, patterns, and insights utilizing modern IT tooling.
- Any relevant certifications (e.g., CBAP, PMI-PBA) or formal training in business analysis and solution development
- Proficiency in using analytical tools and software for data analysis.
- Ability to troubleshoot issues and implement effective resolutions.
- Understanding of technical IT issues to organize discussions with internal and external technical specialists. Must be able to ensure best practices are used for each type of technology infrastructure: client/server, virtual environments (private, AWS, Azure), single or multi-tenant web-based Software as a Service (SaaS) solutions.
Required Work Experience:
- Advanced degree in computer science, technology, engineering, or related disciplines required.
- 7+ years pharmaceutical/biotech company or consulting experience required.
- Experience in clinical development.
- Experience supporting heavily outsourced partner/vendor organizations including CROs/FSPs.
- Experience working with and implementing data platforms and services.
- Experience selecting, designing and implementing IT Applications
- Experience working in both custom developed cloud-based solutions and “as a Service” solutions e.g. IaaS, SaaS, PaaS etc.
- Experience defining data processes & standards and/or data integration mechanisms.
- Experience leading regulated systems in a GxP regulated industry; Computer Software Validation (CSV), and IT SDLC