Dice
Clinical Lab Systems /BUSINESS ANALYST (LIMS)
Dice, Norwood, Massachusetts, us, 02062
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Randstad Digital, is seeking the following. Apply via Dice today!Job Summary:
Clinical Lab Systems - BUSINESS ANALYST (LIMS)The Business Analyst will support the requirement gathering and implementation of Clinical Laboratory Digital software and systems requirements and translate them into business side requirements. Must be comfortable running workshops and driving timely information for both users on both the scientific and business side stakeholders.This person will have an in-depth background in Laboratory Information Management Systems. They will be knowledgeable and SME in process and workflow associated with validation, software deployment, and CSV processes. This is not a validation or CSV role. The Business Analyst will be accustomed to working with these teams and capable of understanding their role in the process.Knowledge of Regulatory process with regards to Clinical and Clinical Lab's within FDA standards is a major plus. This is not a regulatory analyst. This job is directly related to software deployments surrounding LIMS in a clinical environment.You Will:
Elicit end user design workshops for the collection and refinement of personas, epics and user stories. Validate and document business and functional requirements for system features and/or process changes.Author/co-author documents: epics, user stories and associated functional and design documents, Configuration Specifications, Test Plans, Work Instructions, SOPs, etc.Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead user acceptance testing (UAT) efforts to ensure the software implementation meets the needs of business end users.Lead teams of users through support meetings, reviewing key points of concerns and escalating where necessary. Build strong and positive working relationships with all functional areas across the company and understand their needs.Help business stakeholders envision the future and how their work will need to change to support the future. Work in partnership with stakeholders to improve the business processes impacted by technology changes.Approach problem solving and system design from end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows when possible.Support product owners in product backlog grooming and release definition. Post-implementation, evaluate progress made against the business objectives for the project to show the extent to which they were fulfilled. Suggest follow-up projects and initiatives as needed to fully realize the intended objectives.Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements.Analyze and develop interim and future-state business system process documentation that articulates exactly what changes are required.Assist in the authoring and execution of validation artifacts for user acceptance testing and operational qualification testing.Assist in the authoring of procedural documents (SOPs).Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Train end users to ensure they understand all processes and procedural changes. Collaborate with training staff to create appropriate training materials and deliver the training.Collaborate with business stakeholders across clinical operations, bio-sample management and regulatory business units to understand their current and future state goals and objectives from a global perspective in a high growth fast-paced environment.Here's What You'll Bring to the Table:
At least 5 years' experience in the definition, design, implementation and support of solutions in one or multiple clinical and medical systems: LIMS, SDMS, laboratory instrument and analytical software, and sample management systems.You have proven experience with external vendor integration (CRO, central labs, imaging labs etc.), and vendor technology management.Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR).Tangible record of accomplishment in using Agile approaches for product development.Demonstrable experience in Design Thinking.Working knowledge of cloud-based requirement management and agile process management tools (Jira, Confluence, Asana or similar).As a technologist, you know your craft and you are fluent in the digital world. You have first-hand knowledge of technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.You have a working knowledge of clinical, manufacturing or research operations, clinical data management, regulatory processes in a drug development context.You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.You do not hesitate to dive in and work alongside the team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity effectively.You put team before tasks by collaborating actively with all team members and supporting them.A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Bachelor's degree in Computer Science, Biotechnology, Life Science or equivalent required. Master's preferred.Location:
Norwood, MassachusettsJob Type:
ContractSalary:
$70 - 85 per hourWork Hours:
8am to 4pmEducation:
BachelorsResponsibilities:
Document business and functional requirements for system features and process changes.Lead end-user design workshops to refine personas, epics, and user stories.Author or co-author essential documents, including epics, user stories, functional and design documents, Configuration Specifications, Test Plans, Work Instructions, and SOPs.Assist in creating test plans and detailed test cases to ensure functional requirements are met.Lead user acceptance testing (UAT) as needed to confirm that software implementations meet business needs.Lead support meetings with users, review key concerns, and escalate issues as necessary.Build strong relationships with all functional areas and understand their needs.Help stakeholders envision future changes and work in partnership to improve business processes affected by technology changes.Approach problem-solving and system design from the end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows whenever possible.Support product owners in product backlog grooming and release definition.Evaluate progress against business objectives post-implementation and suggest follow-up projects as needed.Assist with systems integration design to deliver maximum efficiency and business value while considering information flow and data requirements.Analyze and develop business system process documentation, clearly articulating required changes.Train end-users on new processes and procedural changes and collaborate with training staff to create and deliver training materials.Collaborate with stakeholders across clinical operations, bio-sample management, and regulatory business units to understand their global goals and objectives in a high-growth, fast-paced environment.Qualifications:
Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required)Skills:
Business AnalysisEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.
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Clinical Lab Systems - BUSINESS ANALYST (LIMS)The Business Analyst will support the requirement gathering and implementation of Clinical Laboratory Digital software and systems requirements and translate them into business side requirements. Must be comfortable running workshops and driving timely information for both users on both the scientific and business side stakeholders.This person will have an in-depth background in Laboratory Information Management Systems. They will be knowledgeable and SME in process and workflow associated with validation, software deployment, and CSV processes. This is not a validation or CSV role. The Business Analyst will be accustomed to working with these teams and capable of understanding their role in the process.Knowledge of Regulatory process with regards to Clinical and Clinical Lab's within FDA standards is a major plus. This is not a regulatory analyst. This job is directly related to software deployments surrounding LIMS in a clinical environment.You Will:
Elicit end user design workshops for the collection and refinement of personas, epics and user stories. Validate and document business and functional requirements for system features and/or process changes.Author/co-author documents: epics, user stories and associated functional and design documents, Configuration Specifications, Test Plans, Work Instructions, SOPs, etc.Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead user acceptance testing (UAT) efforts to ensure the software implementation meets the needs of business end users.Lead teams of users through support meetings, reviewing key points of concerns and escalating where necessary. Build strong and positive working relationships with all functional areas across the company and understand their needs.Help business stakeholders envision the future and how their work will need to change to support the future. Work in partnership with stakeholders to improve the business processes impacted by technology changes.Approach problem solving and system design from end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows when possible.Support product owners in product backlog grooming and release definition. Post-implementation, evaluate progress made against the business objectives for the project to show the extent to which they were fulfilled. Suggest follow-up projects and initiatives as needed to fully realize the intended objectives.Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements.Analyze and develop interim and future-state business system process documentation that articulates exactly what changes are required.Assist in the authoring and execution of validation artifacts for user acceptance testing and operational qualification testing.Assist in the authoring of procedural documents (SOPs).Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Train end users to ensure they understand all processes and procedural changes. Collaborate with training staff to create appropriate training materials and deliver the training.Collaborate with business stakeholders across clinical operations, bio-sample management and regulatory business units to understand their current and future state goals and objectives from a global perspective in a high growth fast-paced environment.Here's What You'll Bring to the Table:
At least 5 years' experience in the definition, design, implementation and support of solutions in one or multiple clinical and medical systems: LIMS, SDMS, laboratory instrument and analytical software, and sample management systems.You have proven experience with external vendor integration (CRO, central labs, imaging labs etc.), and vendor technology management.Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR).Tangible record of accomplishment in using Agile approaches for product development.Demonstrable experience in Design Thinking.Working knowledge of cloud-based requirement management and agile process management tools (Jira, Confluence, Asana or similar).As a technologist, you know your craft and you are fluent in the digital world. You have first-hand knowledge of technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.You have a working knowledge of clinical, manufacturing or research operations, clinical data management, regulatory processes in a drug development context.You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.You do not hesitate to dive in and work alongside the team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity effectively.You put team before tasks by collaborating actively with all team members and supporting them.A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Bachelor's degree in Computer Science, Biotechnology, Life Science or equivalent required. Master's preferred.Location:
Norwood, MassachusettsJob Type:
ContractSalary:
$70 - 85 per hourWork Hours:
8am to 4pmEducation:
BachelorsResponsibilities:
Document business and functional requirements for system features and process changes.Lead end-user design workshops to refine personas, epics, and user stories.Author or co-author essential documents, including epics, user stories, functional and design documents, Configuration Specifications, Test Plans, Work Instructions, and SOPs.Assist in creating test plans and detailed test cases to ensure functional requirements are met.Lead user acceptance testing (UAT) as needed to confirm that software implementations meet business needs.Lead support meetings with users, review key concerns, and escalate issues as necessary.Build strong relationships with all functional areas and understand their needs.Help stakeholders envision future changes and work in partnership to improve business processes affected by technology changes.Approach problem-solving and system design from the end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows whenever possible.Support product owners in product backlog grooming and release definition.Evaluate progress against business objectives post-implementation and suggest follow-up projects as needed.Assist with systems integration design to deliver maximum efficiency and business value while considering information flow and data requirements.Analyze and develop business system process documentation, clearly articulating required changes.Train end-users on new processes and procedural changes and collaborate with training staff to create and deliver training materials.Collaborate with stakeholders across clinical operations, bio-sample management, and regulatory business units to understand their global goals and objectives in a high-growth, fast-paced environment.Qualifications:
Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required)Skills:
Business AnalysisEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.
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