Business System AnalystUnited Software Group • Cambridge, MA, United States
[error_messages.no_longer_accepting]
Business System Analyst
United Software Group • Cambridge, MA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Requirements Gathering and Analysis : Collaborate with the business teams across R&D and Enterprise Operations to gather and analyze requirements for IT projects. Design, develop and document supporting business processes and translate these into functional and non-functional requirements or user stories. Solution Design : Work with the Enterprise Architect and IT development team to design and / or specify technology solutions that meet business needs. Ensure that the solution can integrate with existing technology landscape and if required, complies with GxP (Good Practice) guidelines and regulatory requirements i.e FDA 21 CFR Part 11 Solution Delivery : Ensure that all IT solutions comply with internal standards and required regulatory requirements. Participate in the Computer Systems Validation (CSV) process including the creation and execution of test plans to ensure the compliance and efficacy of the system. For non GxP processes ensure compliance with SDLC process and produce deliverables where responsible. Project Management Support : Assist the project manager or PMO in the planning, execution and monitoring of IT projects, ensuring they are delivered on time, within scope and budget. Work with the project manager and scrum person to ensure that the project can meet its required deadlines. Identify and project risks and issues, working with IT teams to propose mitigation strategies. Stakeholder Communication and Management : Act as a liaison between IT and the business functions, ensuring clear communication and understanding of requirements, timelines and project statues. Facilitate and lead workshops to ensure alignment and consensus amongst the stakeholders. System Maintenance and Continuous Improvement : Ensure that systems are maintained and updated post go live (where assigned) working closely with the business owner to ensure any enhancements or bug-fix issues are planned for and remediated. Recommend improvements to business processes and IT solutions, driving innovation and efficiency within the company. Suggest new and emerging technologies and trends in the pharmaceutical industry that could benefit the Institute. Superior communication (verbal and written) and presentation skills with the ability to effectively advocate technical solutions and results to technology and business audiences. Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities. Ability to work independently and collaboratively with cross-functional / inter-departmental teams and within the framework of the Enterprise Operations IT organization. Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able to deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation. Team-oriented and generous in sharing knowledge and enabling others. Strong communication and facilitation skills to lead teams to establish consensus, ensure clarity and decisions / justifications. Effective negotiation and persuasion skills to manage stakeholder expectations. Excellent time management and the ability to prioritize tasks effectively. Attention to detail in documenting requirements, creating reports, and managing project documentation. Creative and critical thinking skills to develop innovative solutions to business challenges. Strong understanding of agile concepts and certification in agile methodology Strong understanding of modern data systems and tools including data platforms, data warehouses, data lakes, data ingestion, distribution pipelines, and data analytics / visualization how to apply this knowledge to clinical and real-world data. Strong Pharma / Life Sciences experience with an in-depth understanding of Clinical Development and Operations processes Strong understanding and working knowledge of : Clinical Trial Data (STDM, ADaM, DTD, eCTD / XML) Nonclinical Study Data (SEND) Safety Data (ISO / HL7 27953 : E2B(r2), E2B(r3); ICSR, PADER, PSUR, DSUR) Experience working in a Computer System Validation (CSV) process and SDLC process. Understanding and experience with Pharma related Technology Solutions / Platforms, including but not limited to : Strong understanding and experience designing solutions and working in and Azure and AWS Cloud Environments Understanding of software development processes and methodologies (e.g., Agile, Scrum, Waterfall, SDLC). Certified and experienced in working within an agile framework e.g. SaFe and as part of an agile team. Able to work within Jira and is proficient in creating and managing Epics, User Stories and Tasks. Able to analyze complex data to identify trends, patterns, and insights utilizing modern IT tooling. Any relevant certifications (e.g., CBAP, PMI-PBA) or formal training in business analysis and solution development Proficiency in using analytical tools and software for data analysis. Ability to troubleshoot issues and implement effective resolutions. Understanding of technical IT issues to organize discussions with internal and external technical specialists. Must be able to ensure best practices are used for each type of technology infrastructure : client / server, virtual environments (private, AWS, Azure), single or multi-tenant web-based Software as a Service (SaaS) solutions. Advanced degree in computer science, technology, engineering, or related disciplines required. 7+ years pharmaceutical / biotech company or consulting experience required. Experience in clinical development. Experience supporting heavily outsourced partner / vendor organizations including CROs / FSPs. Experience working with and implementing data platforms and services. Experience selecting, designing and implementing IT Applications Experience working in both custom developed cloud-based solutions and "as a Service" solutions e.g. IaaS, SaaS, PaaS etc. Experience defining data processes & standards and / or data integration mechanisms. Experience leading regulated systems in a GxP regulated industry; Computer Software Validation (CSV), and IT SDLC 676
Job Description : Must Haves :
- 7+ years as a BSA
- Strong background in clinical research, GxP, and CSV environments
- Understanding data pipelines and gathering heavy data requirements
This position is responsible for bridging the gap between business needs and technical solutions and plays a pivotal role in ensuring that the solutions developed and implemented by IT align with our business strategies, objectives and processes. The position requires people with a blend of technical, analytical and interpersonal skills and how to apply these in the Pharmaceutical Industry. They will need to understand how to work with both GxP and non-GxP systems and a good understanding of the Clinical (Drug) Development Lifecycle.
The Business Analyst will be involved throughout the project lifecycle from initial concept through to delivery and post implementation support. They will be responsible for facilitating communication between stakeholders and IT Professionals, ensuring that the solutions developed address business problems and add value. They will be directly responsible for requirements gathering and analysis, modelling business and IT processes, managing project scopes, solutions design, in scope testing and ongoing user and system support.
Responsibilities :
Skills & Abilities :
Required Technical Knowledge / Experience / Skills :
GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)
PV Safety Databases / Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
Required Work Experience :
Regards
Jaya Kushwaha
Associate Manager | Recruitment
Email : jaya.k@usgrpinc.com
Work Phone : 614-495-9222
USG Inc.
[job_alerts.create_a_job]
System Analyst • Cambridge, MA, United States
[internal_linking.similar_jobs]
Confidential (Large Investment Firm).Hybrid - 3 days a week onsite in Boston, MA.Performs analysis of business activities to determine business requirements.
Works with business users to understand ...[show_more]
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 healthca...[show_more]
Business Systems Analyst (Hybrid) | USC, GC, H4 EAD | Boston, MA.Location : Boston, MA (Hybrid Local candidates only).I am excited to share a new opportunity for a.
We are looking for a detail-orien...[show_more]
Bachelor's degree or equivalent experience in finance, economics, computer science, or technology related field.Minimum of 2-5+ years of experience in the financial services industry, ideally suppo...[show_more]
Our client cannot sponsor visas at this time (must be US Citizen or GC Permanent Resident) • •.The Clinical Business System Analyst is responsible for business process analysis and the development / ma...[show_more]
Title : Sr Business Systems Analyst Location : Boston , MA or Qunicy , MA ( 4 days onsite ) Initial panel interview senior members of the team via v...[show_more]
The Business Systems Analyst will provide analytical expertise to support a variety of analytic initiatives within the Data Operations and Technology team.
The Business Systems Analyst will research...[show_more]
Business Systems Senior Analyst.DMV IT Service LLC, founded in 2020, is a trusted IT consulting firm specializing in IT infrastructure optimization, cybersecurity, networking, and staffing solution...[show_more]
Hello There, Wish you a Happy Thursday, My name is Yashmita, and I am a Technical Recruiter at Kanak IT Services LLC.I am...[show_more]
Senior Business Systems Analyst.This role is with a DeWinter Financial Services Partner.Boston, MA - Hybrid Role - We are targeting local candidates that can be in the Boston office 3 days per week...[show_more]
Senior Discovery Business and System Analyst.Employment Type : Full-Time, Executive-Level.Department : Legal .CGS is seeking a dedicated Senior Discovery Business and System Analyst to jo...[show_more]
Database Systems Analyst (iManage).Boston, New York, or Washington, DC.Working with the Database Systems team within the Information Technology Department, and collaborating closely with the DMS Ad...[show_more]
Job Title : Business Systems Analyst Oracle ERP ( Manufacturing).Fluke Corporation a global leader in manufacturing is seeking a.
Oracle ERP Applications ( Manufacturing modules).Youll leverage Orac...[show_more]
Mid-Level Business and Systems Analyst.The Boeing Company is currently seeking a.Mid-Level Business and Systems Analyst.Everett WA.
Auburn WA; Seattle WA; or Renton WA.This individual will join the...[show_more]
At WHOOP, we're on a mission to unlock human performance and healthspan.WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.WHOOP ...[show_more]
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 heal...[show_more]
You will be responsible for systems implementation and administration within Facilities Development & Operations including but not limited to : software applications / upgrades, database administratio...[show_more]
The Business Analyst can work from either Boston, MA or Springfield, MA office in Hybrid capacity.Processes and Technology to execute on supporting our customer and employee experiences.Document bu...[show_more]
Sr. Business Systems Analyst (Boston)
MSH • Boston, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
5836 - Business System Specialist / Senior Data Analyst
Verista • Boston, Massachusetts, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Business System Analyst (Boston)
Saxon Global • Boston, MA, US
[job_card.part_time]
[last_updated.last_updated_1_day] • [promoted]
Financial Services Business Systems Analyst (Boston)
Gardner Resources Consulting, LLC • Boston, MA, US
[job_card.part_time]
[last_updated.last_updated_variable_days] • [promoted]
Clinical Business Systems Analyst (Boston)
Talent Groups • Boston, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Sr Business Systems Analyst
Akaasa Technologies • Boston, MA, United States
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_variable_days]
Business Analyst
TalentBurst, Inc. • Boston, MA, US
[job_card.permanent]
[last_updated.last_updated_variable_days] • [promoted]
Business Systems Senior Analyst
DMV IT Service • Boston, MA, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Business Systems Analyst
Kanak Elite Services Inc • Boston, MA, United States
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_variable_days]
Senior Business Systems Analyst (Boston)
DeWinter Group • Boston, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Senior Discovery Business and System Analyst (Top Secret Clearance Required)
Contact Government Services, LLC • Boston, MA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Database Systems Analyst (iManage)
Open Systems Technologies • Boston, MA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Business Systems Analyst – Oracle Manufacturing
Fortive • Everett, Massachusetts, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Mid-Level Business and Systems Analyst
Boeing • Everett, Massachusetts, USA
[job_card.full_time] +1
[last_updated.last_updated_1_day] • [promoted]
Senior NetSuite Business Systems Analyst
Whoop • Boston, MA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
5836 - Business System Specialist / Senior Data Analyst
Verista, Inc. • Boston, MA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Business Systems Specialist (hybrid)
American Family Insurance • Boston, Massachusetts, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Business Analyst (Boston)
Masis Professional Group • Boston, MA, US
[job_card.part_time]
[last_updated.last_updated_variable_days] • [promoted]