Veristas 600 experts team up with the worlds 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 worlds 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 manorHighlight 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 stakeholdersRequirementsExperience 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 remotelyBachelors 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 processesTo 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 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 proceduresBenefitsWhy 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.com (https://apply.workable.com/verista/)For 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.

Veristas 600 experts team up with the worlds 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 worlds 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: Role: Senior Business Analyst (Veeva Quality Docs Implementation) Facilitate working sessions with business end-user representatives, IT representatives and vendors to update existing or draft new requirements resulting from process or configuration changes and enhancements. Manage the review and approval cycles for RS Participate in ST or UAT activities, including: Developing system/user testing scenarios and checklists based on the business process and requirements Participate in the planning, scheduling and oversight of UAT testing activities Assist with updates of user training documentation - Quick Reference Guides; User Guides Manage the activities associated with the draft, review and approval of system SOPs and Work Instructions Review SDLC deliverables for completeness, accuracy and applicability Participate in the organizational change management and user adoption process Perform and document gap analysis between systems/processes Contribute to the authoring of documentation such as: Solution Implementation Plans and Summaries Test Plans and Summaries Requirement Traceability Matrix Requirements Bachelors degree or higher required. 7 years of business analysis experience in the pharmaceutical industry required. Flexible schedule that allows for work activities during times that align with different time zones. Solid understanding of Veeva Quality Docs systems, data and processes required. Experience implementing/validating Veeva Quality Docs capabilities required, with a strong understanding of SDLC deliverables. Preferred: Strong understanding of system integrations, including but not limited to, understanding of how integrations are designed / constructed, and data flow from source systems to target systems. Benefits Why Choose Verista? 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 For more information about our company, please visit us at Verista.com (https://apply.workable.com/verista/) For 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. $87,780-134,000 Verista is an equal opportunity employer.

<h3>Job Description</h3><div>Job Description<div>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:<ul><li>We empower and support our colleagues</li><li>We commit to client success at every turn</li><li>We have the courage to do the right thing</li><li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li><li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li></ul>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:<ul><li>Author and refine system support processes, operational procedure documents (SOPs), flow diagrams, configurations, and interdependencies</li><li>Author product release notes and communications for end users/ business stakeholders</li><li>Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.</li><li>Effectively translates business requirements into user stories and supporting documents like detailed requirement specifications, data mapping (STTMs) for the agile development team</li><li>Support product owner by aligning with business system owner for prioritizing the product backlog</li><li>Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes</li><li>Complete upgrades and enhancements to existing applications</li><li>Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure</li><li>Independently deliver projects and initiatives in a timely and qualitative manor</li><li>Highlight potential risks and act proactively to resolve issues</li><li>Follow company and departmental policies, procedures and ensure documentation according to the Client Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards</li><li>Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability</li><li>Establish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processes</li><li>Build and maintain relationships with key business stakeholders</li></ul>Requirements<ul><li>Experience working in R&D and/or Biotech preferred</li><li>Working knowledge of clinical data systems such EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMF</li><li>Experience working with global teams remotely</li><li>Bachelor’s degree or equivalent in a science discipline or related field</li><li>7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions</li><li>Working Knowledge of managing requirements for AWS Cloud solutions and related services in Clinical data space</li><li>Proficient knowledge of Quality process Assurance/Compliance,21 CFR Part 11, and other regulations (GXP) required</li><li>Proficient in working within an SDLC framework (Delivery, Testing, Software Quality Assurance, Change Management)</li><li>Hands on Agile tools like Atlassian Suite (JIRA/Confluence)</li><li>Ability to articulate complex technical problems and solutions to a wide business audience and communicate solution value</li><li>Familiarity with change control and SDLC associated with computer system validation processes</li></ul>To better align with the position, candidates with under 15 years of experience would be ideal with following key skills:<ul><li>Solid understanding of Agile SDLC concepts with working knowledge of tools like JIRA and Confluence</li><li>Ability to articulate technical requirements in user stories for clinical data system implementations and integrations</li><li>Experience in gathering requirements for cloud-based applications, particularly on AWS</li><li>Proficiency in managing use case requirements, conducting knowledge transfers with developers and testers, and supporting UAT with stakeholders</li><li>Knowledge of Quality Process Assurance/Compliance, 21 CFR Part 11, GxP regulations, and validation procedures</li></ul>BenefitsWhy Choose Verista?<ul><li>High growth potential and fast-paced organization with a people-focused culture</li><li>Competitive pay plus performance-based incentive programs</li><li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li><li>Medical, Dental & Vision insurances</li><li>FSA, DCARE, Commuter Benefits</li><li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li><li>Health Savings Account</li><li>401(k) Retirement Plan (Employer Matching benefit)</li><li>Paid Time Off (Rollover Option) and Holidays</li><li>As Needed Sick Time</li><li>Tuition Reimbursement</li><li>Team Social Activities (We have fun!)</li><li>Employee Recognition</li><li>Employee Referral Program</li><li>Paid Parental Leave and Bereavement</li></ul>For more information about our company, please visit us at Verista.com For 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.</div></div>

<h3>Job Description</h3><div>Job Description<div>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:<ul><li>We empower and support our colleagues</li><li>We commit to client success at every turn</li><li>We have the courage to do the right thing</li><li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li><li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li></ul>Senior Business Analyst Responsibilities:Role: Senior Business Analyst (Veeva Quality Docs Implementation)<ul><li>Facilitate working sessions with business end-user representatives, IT representatives and vendors to update existing or draft new requirements resulting from process or configuration changes and enhancements. Manage the review and approval cycles for RS</li></ul> Participate in ST or UAT activities, including:<ul><li>Developing system/user testing scenarios and checklists based on the business process and requirements</li><li>Participate in the planning, scheduling and oversight of UAT testing activities</li><li>Assist with updates of user training documentation - Quick Reference Guides; User Guides</li><li>Manage the activities associated with the draft, review and approval of system SOPs and Work Instructions</li><li>Review SDLC deliverables for completeness, accuracy and applicability</li><li>Participate in the organizational change management and user adoption process</li><li>Perform and document gap analysis between systems/processes</li></ul> Contribute to the authoring of documentation such as:<ul><li>Solution Implementation Plans and Summaries</li><li>Test Plans and Summaries</li><li>Requirement Traceability Matrix</li></ul>Requirements<ul><li>Bachelor’s degree or higher required.</li><li>7+ years of business analysis experience in the pharmaceutical industry required.</li><li>Flexible schedule that allows for work activities during times that align with different time zones.</li><li>Solid understanding of Veeva Quality Docs systems, data and processes required.</li><li>Experience implementing/validating Veeva Quality Docs capabilities required, with a strong understanding of SDLC deliverables.</li></ul> Preferred:<ul><li>Strong understanding of system integrations, including but not limited to, understanding of how integrations are designed / constructed, and data flow from source systems to target systems.</li></ul>BenefitsWhy Choose Verista?<ul><li>High growth potential and fast-paced organization with a people-focused culture</li><li>Competitive pay plus performance-based incentive programs</li><li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li><li>Medical, Dental & Vision insurances</li><li>FSA, DCARE, Commuter Benefits</li><li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li><li>Health Savings Account</li><li>401(k) Retirement Plan (Employer Matching benefit)</li><li>Paid Time Off (Rollover Option) and Holidays</li><li>As Needed Sick Time</li><li>Tuition Reimbursement</li><li>Team Social Activities (We have fun!)</li><li>Employee Recognition</li><li>Employee Referral Program</li><li>Paid Parental Leave and Bereavement</li></ul>For more information about our company, please visit us at Verista.com For 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.$87,780-134,000*Verista is an equal opportunity employer.</div></div>

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