• Work closely with Clinical, Medical Affairs, and Regulatory affairs groups to understand the business needs and document the current business process and the future state.
• Work closely with business and author user requirement specification (URS).
• Build internal IT SOPs for the system owned by the Clinical systems.
• Assist with the writing of and education of business users to generate test scripts.

Responsibilities

• Development of user requirement specifications and associated use cases.
• Definition of process maps and optimized approaches to fulfil user requirements.
• Traceability mapping and other analysis documentation as required.
• Analyze clinical processes, data flows, and data needs to identify solution opportunities, enhancements, data mapping and integration needs.
• Work closely with product owners, development teams, and users to interpret solution demand, refine user requirements/stories, and prioritize backlog tasks.
• Work closely with project leads and other key stakeholders to Identify and manage risks and issues associated with collected demands, report on progress and outcomes.
• Participate in required meetings to communicate status and outcomes.
• Ensure compliance with industry processes and regulations.
• Draft User acceptance test scripts (UAT), review, and dry run with the business team.

Requirements:

• Minimum of 5 years of experience as a business analyst or similar type role in Pharmaceutical Industry.
• Bachelor’s or master’s degree in computer science, information systems, business, healthcare, or a related field.
• Strong understanding of R&D clinical processes and data, knowledgeable of data management practices. Familiar with industry regulations and best practices.
• Good Understanding of GxP processes
• Excellent analytical skills and proven ability to collaborate cross-functionally with stakeholders to capture value driven requirements and translate to solution outcomes.
• Familiar with agile project management and data management processes, experienced in data platforms and landscapes.
• Experience leading requirements gathering, analysis, and documentation.
• Strong skills in user requirements elicitation and process definition for application in technology solutions.
• Excellent verbal and written communication skills
• Knowledgeable of industry standards and best practices, with a problem-solving mindset.
• Ability to work well on concurrent multidisciplinary projects.
• Experience working in a fast paced rapidly growing company.
• Experience with pharma applications including Veeva RIM, Veeva Medcomms & Promomats is a plus.