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

$80,465 - $116,843/Yr

Verista - Cambridge, MA

Full-time - Mid Level

Cambridge, MA

501-1,000 employees

About the position

The Senior Business Analyst at Verista plays a crucial role in managing clinical data requirements and supporting the development of DevTech Products, particularly the Clinical Data Lake. This position requires a seasoned professional with over 7 years of experience to act as a subject matter expert, ensuring that business requirements are effectively translated into actionable user stories and supporting documentation. The role involves collaboration with various teams, including testing and product ownership, to deliver projects that comply with regulatory standards and enhance existing applications.

Responsibilities

• 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 translate business requirements into user stories and supporting documents like detailed requirement specifications and 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 manner.
• 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

• 7+ years of experience in managing clinical data requirements.
• Experience working in R&D and/or Biotech preferred.
• Working knowledge of clinical data systems such as 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 experience with 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.

Nice-to-haves

• 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 and integrations.
• Experience in gathering requirements for cloud-based applications, particularly on AWS.
• Proficiency in managing use case requirements, conducting knowledge transfers with developers and testers, and supporting UAT with stakeholders.
• Knowledge of Quality Process Assurance/Compliance, 21 CFR Part 11, GxP regulations, and validation procedures.

Benefits

• High growth potential and fast-paced organization with a people-focused culture.
• Competitive pay plus performance-based incentive programs.
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances.
• FSA, DCARE, Commuter Benefits.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance.
• Health Savings Account.
• 401(k) Retirement Plan (Employer Matching benefit).
• Paid Time Off (Rollover Option) and Holidays.
• As Needed Sick Time.
• Tuition Reimbursement.
• Team Social Activities (We have fun!).
• Employee Recognition.
• Employee Referral Program.
• Paid Parental Leave and Bereavement.