Verista
Senior Business Analyst (Clinical Data Lake) / Sr Business Analyst - 5231
Verista, Cambridge, Massachusetts, us, 02140
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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseSenior 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 interdependenciesAuthor product release notes and communications for end users/ business stakeholdersPartner 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 teamSupport product owner by aligning with business system owner for prioritizing the product backlogParticipate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changesComplete upgrades and enhancements to existing applicationsEnsure compliance with regulatory requirements/controls related to business systems and IT infrastructureIndependently deliver projects and initiatives in a timely and qualitative mannerHighlight potential risks and act proactively to resolve issuesFollow company and departmental policies, procedures and ensure documentation according to the Client Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standardsWork independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountabilityEstablish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processesBuild and maintain relationships with key business stakeholdersQualifications:Experience working in R&D and/or Biotech preferredWorking knowledge of clinical data systems such EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMFExperience working with global teams remotelyBachelor’s degree or equivalent in a science discipline or related field7-10 years of pharmaceutical industry or related experience in implementing Clinical solutionsWorking Knowledge of managing requirements for AWS Cloud solutions and related services in Clinical data spaceProficient knowledge of Quality process Assurance/Compliance, 21 CFR Part 11, and other regulations (GXP) requiredProficient 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 valueFamiliarity with change control and SDLC associated with computer system validation processesIdeal Candidate:Solid understanding of Agile SDLC concepts with working knowledge of tools like JIRA and ConfluenceAbility to articulate technical requirements in user stories for clinical data system implementations and integrationsExperience in gathering requirements for cloud-based applications, particularly on AWSProficiency in managing use case requirements, conducting knowledge transfers with developers and testers, and supporting UAT with stakeholdersKnowledge of Quality Process Assurance/Compliance, 21 CFR Part 11, GxP regulations, and validation proceduresWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us at
Verista.comFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.$80,465-116,843*Verista is an equal opportunity employer.
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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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseSenior 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 interdependenciesAuthor product release notes and communications for end users/ business stakeholdersPartner 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 teamSupport product owner by aligning with business system owner for prioritizing the product backlogParticipate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changesComplete upgrades and enhancements to existing applicationsEnsure compliance with regulatory requirements/controls related to business systems and IT infrastructureIndependently deliver projects and initiatives in a timely and qualitative mannerHighlight potential risks and act proactively to resolve issuesFollow company and departmental policies, procedures and ensure documentation according to the Client Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standardsWork independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountabilityEstablish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processesBuild and maintain relationships with key business stakeholdersQualifications:Experience working in R&D and/or Biotech preferredWorking knowledge of clinical data systems such EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMFExperience working with global teams remotelyBachelor’s degree or equivalent in a science discipline or related field7-10 years of pharmaceutical industry or related experience in implementing Clinical solutionsWorking Knowledge of managing requirements for AWS Cloud solutions and related services in Clinical data spaceProficient knowledge of Quality process Assurance/Compliance, 21 CFR Part 11, and other regulations (GXP) requiredProficient 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 valueFamiliarity with change control and SDLC associated with computer system validation processesIdeal Candidate:Solid understanding of Agile SDLC concepts with working knowledge of tools like JIRA and ConfluenceAbility to articulate technical requirements in user stories for clinical data system implementations and integrationsExperience in gathering requirements for cloud-based applications, particularly on AWSProficiency in managing use case requirements, conducting knowledge transfers with developers and testers, and supporting UAT with stakeholdersKnowledge of Quality Process Assurance/Compliance, 21 CFR Part 11, GxP regulations, and validation proceduresWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us at
Verista.comFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.$80,465-116,843*Verista is an equal opportunity employer.
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