Analyse the business requirements and elicit the functional specifications to effectively develop an IT solution concept. Collaborate cross-functionally to transform the functional specifications to technical requirements, ultimately leading to meeting the business expectations while assuring solutions are safe, compliant, reliable, scalable, and flexible. Understand the overall end to end process and develop business process workflows detailing out the key functionalities and risks with the process / functions. Engage with global business leaders and leverage the appropriate DDIT teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and generate value.

• Well versed with the overall end to end processes in the pharma domain including but not limited to clinical trial design, conduct, data analysis and reporting to name a few.
• Knowledge of the regulatory compliance requirements is a must. Knowledge of / experience with systems used in pharma domain would be an advantage.
• Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing as appropriate and ensure adherence to Security and Compliance policies and procedures within Service Delivery scope.
• Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
• Develop project rationale and perform scoping assessments to determine feasibility of projects. Conduct interviews with business team members to understand the key dependencies with business processes.
• Develop and depict (in Visio, Miro, enterprise architect or equivalent) a clear end to end business process flow(s) diagram to ensure the specifications strategically fit in the big picture view.
• Highlight/identify gaps in existing functionality and drive requirements review with stakeholders. Develop clear and comprehensive requirement specifications that will determine the estimate of cost, time, and resources to deploy solutions.
• Liaise with the service development team to suggest a high-level functional solution. Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)
• Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services. Ensure the overall user experience is considered when designing and deploying new solutions and services.
• Ensure consistency, traceability and test coverage between user requirements, functional specifications, and testing & validation. Support validation and testing (OQ, PQ, UAT…)Preparation/ update of a Functional Risk Assessment.
• Perform change impact assessment and formulate a right and compliant approach to development and deployment of changes. Ensure implemented solutions are according to specifications and fit for purpose.
• Support super user training. Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security)

Education & Qualifications

• University degree in Informatics, Computer Sciences, Life Sciences or similar

Experience

• A minimum of 10+ years of experience in working in the Pharma or IT Industry and 8+ years of experience in the Pharma domain
• 6+ years of experience as a business analyst/process expert/ business IT lead superuser
• Expert understanding of business process analysis & design and system architecture concepts.
• Expert understanding of the Clinical Trial Business processes, End to End drug development process experience an advantage.
• Expert knowledge of GxP, 21CFR Part 11 and the CSV lifecycle
• Knowledge of EDC systems, Clinical Data Platforms, Statistical Computing Environments and Clinical Data Management is desirable
• Prior working experience in Clinical Analytics domain and knowledge on business processes is preferred.
• Experience as a Product Owner for Platforms or Large complex solution is an added advantage.
• Ability to solve complex business process / information challenges.
• Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
• Working knowledge of product management, agile methodologies an advantage.
• Exposure/working experience in digital innovation projects is an added advantage.
• Data Strategy, Data science or data standardization experience an advantage