Verista
Senior Business Analyst (Clinical Data Lake) / Sr Business Analyst
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 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 Client 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 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
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.
$80,465-116,843
*Verista is an equal opportunity employer.
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 Client 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 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
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.
$80,465-116,843
*Verista is an equal opportunity employer.