Senior Business Analyst (Clinical Data Lake) / Sr Business Analyst - 5231

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Senior Business Analyst Responsibilities:

Senior Business Analyst with 7+ years of experience in managing clinical data requirements, will be responsible for planning, business requirement/user story development in support of our DevTech Products and will act as a primary subject matter expert for support for teams using assigned Product i.e. Clinical Data Lake.

Functional Requirements:

• Author and refine system support processes, operational procedure documents (SOPs), flow diagrams, configurations, and interdependencies
• Author product release notes and communications for end users/ business stakeholders
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.
• Effectively translates business requirements into user stories and supporting documents like detailed requirement specifications, data mapping (STTMs) for the agile development team
• Support product owner by aligning with business system owner for prioritizing the product backlog
• Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes
• Complete upgrades and enhancements to existing applications
• Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure
• Independently deliver projects and initiatives in a timely and qualitative manor
• Highlight potential risks and act proactively to resolve issues
• Follow company and departmental policies, procedures and ensure documentation according to the Takeda Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards
• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability
• Establish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processes
• Build and maintain relationships with key business stakeholders

Requirements

• Experience working in R&D and/or Biotech preferred
• Working knowledge of clinical data systems such EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMF
• Experience working with global teams remotely
• Bachelor’s degree or equivalent in a science discipline or related field
• 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions
• Working Knowledge of managing requirements for AWS Cloud solutions and related services in Clinical data space
• Proficient knowledge of Quality process Assurance/Compliance,21 CFR Part 11, and other regulations (GXP) required
• Proficient in working within an SDLC framework (Delivery, Testing, Software Quality Assurance, Change Management)
• Hands on Agile tools like Atlassian Suite (JIRA/Confluence)
• Ability to articulate complex technical problems and solutions to a wide business audience and communicate solution value
• Familiarity with change control and SDLC associated with computer system validation processes

To better align with the position, candidates with under 15 years of experience would be ideal with following key skills:

• Solid understanding of Agile SDLC concepts with working knowledge of tools like JIRA and Confluence
• Ability to articulate technical requirements in user stories for clinical data system implementations an