Senior Clinical Trials IT Business Analyst
Job Title: Senior Clinical Trials IT Business Analyst
Department: Information Technology
Location: Remote
Hours Per Week: 40
Schedule: Days; Monday - Friday
SUMMARY
The Senior Clinical Trials IT Business Analyst (Sr. CT IT BA) serves as a strategic liaison between Clinical Development and Information Technology. This role leads the analysis, design, implementation, and optimization of clinical trial technology solutions to support global clinical research operations.
REPONSIBILITIES
Business & Technical Analysis: Obtain, analyze, and document detailed business, functional, and technical requirements, translate clinical / non-clinical operational needs into system configurations and technical solutions, develop Business Requirements Documents (BRDs), functional specifications, user stories & acceptance criteria, business process flow diagrams, and data flow diagrams, conduct system impact assessments and gap analyses, support system integration design across enterprise platforms.
Systems Implementation & Lifecycle Management: lead or support implementation, upgrade, enhancements, optimization and maintenance of Lab Information Management Systems (LIMS), Lab Information Systems (LIS), Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks (ELM), Validation Lifecycle Management (VLM), configure and support system enhancements, oversee vendor coordination and technical solution delivery, support the management of system change requests and release management processes.
Validation & Compliance (GxP): support Computer System Validation (CSV) and / or Computer System Assurance (CSA) activities such as validation plans, risk assessments, IQ/OQ/PQ test script development/documentation, user requirements & documentation, support the development of System Management Plan (SMP), Trace Matrix and other validation documentation as required, ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, MOH, participate in audit and inspection readiness efforts.
Integration & Data Management: collaborate with IT architecture teams on system integrations (APIs, HL7, middleware), ensure data integrity, traceability, and consistency across platforms, support data migration, master data governance, and reconciliation processes, partner with operational teams to define reporting requirements.
Testing & Deployment: lead User Acceptance Testing (UAT), develop test scripts, coordinate execution, support the manage defect tracking & resolution, support regression testing and release validation, facilitate system deployment and post-go-live support.
Stakeholder & Project Engagement: act as primary IT liaison for Clinical business stakeholders. facilitate workshops and requirements sessions, support Agile, PMBOK, or hybrid project methodologies, contribute to project plans, risk logs, and status reporting, provide training and change management support.
REQUIRED QUALIFICATIONS
Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or related field.
3 years of experience in clinical research and/or clinical IT systems (i.e STARLIMS Life Sciences)
3 years in Business Analysis within regulated (GxP) environments.
PREFERRED QUALIFICATIONS
Master’s degree (MBA, MS, MPH, MHA) preferred.
CBAP, PMI-PBA, PMP, or Agile certifications.
Experience in global clinical trial environments.
Knowledge of CDISC, SDTM, and clinical data standards.
Experience with reporting tools (Power BI, Tableau, Qlik, Other).Familiarity with cloud-based clinical systems (e.g., Veeva, Medidata, Oracle Clinical, BioClinical, etc.).
Strong understanding of the lab clinical trial lifecycle.
Hands-on experience with LIMS/LIS clinical platforms (i.e STARLIMS Life Sciences)
Experience with system validation and regulatory compliance.
Familiarity with system integrations and data workflows.
Strong analytical and systems-thinking mindset
Technical fluency in enterprise applications
Regulatory compliance expertise
Cross-functional leadership
Vendor management skills
Excellent communication and documentation skills
EDUCATION:
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.
PAY RANGE:
$100,000.00 - $130,000.00
CITY:
Rochester
POSTAL CODE:
14624
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
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Department: Information Technology
Location: Remote
Hours Per Week: 40
Schedule: Days; Monday - Friday
SUMMARY
The Senior Clinical Trials IT Business Analyst (Sr. CT IT BA) serves as a strategic liaison between Clinical Development and Information Technology. This role leads the analysis, design, implementation, and optimization of clinical trial technology solutions to support global clinical research operations.
REPONSIBILITIES
Business & Technical Analysis: Obtain, analyze, and document detailed business, functional, and technical requirements, translate clinical / non-clinical operational needs into system configurations and technical solutions, develop Business Requirements Documents (BRDs), functional specifications, user stories & acceptance criteria, business process flow diagrams, and data flow diagrams, conduct system impact assessments and gap analyses, support system integration design across enterprise platforms.
Systems Implementation & Lifecycle Management: lead or support implementation, upgrade, enhancements, optimization and maintenance of Lab Information Management Systems (LIMS), Lab Information Systems (LIS), Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks (ELM), Validation Lifecycle Management (VLM), configure and support system enhancements, oversee vendor coordination and technical solution delivery, support the management of system change requests and release management processes.
Validation & Compliance (GxP): support Computer System Validation (CSV) and / or Computer System Assurance (CSA) activities such as validation plans, risk assessments, IQ/OQ/PQ test script development/documentation, user requirements & documentation, support the development of System Management Plan (SMP), Trace Matrix and other validation documentation as required, ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, MOH, participate in audit and inspection readiness efforts.
Integration & Data Management: collaborate with IT architecture teams on system integrations (APIs, HL7, middleware), ensure data integrity, traceability, and consistency across platforms, support data migration, master data governance, and reconciliation processes, partner with operational teams to define reporting requirements.
Testing & Deployment: lead User Acceptance Testing (UAT), develop test scripts, coordinate execution, support the manage defect tracking & resolution, support regression testing and release validation, facilitate system deployment and post-go-live support.
Stakeholder & Project Engagement: act as primary IT liaison for Clinical business stakeholders. facilitate workshops and requirements sessions, support Agile, PMBOK, or hybrid project methodologies, contribute to project plans, risk logs, and status reporting, provide training and change management support.
REQUIRED QUALIFICATIONS
Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or related field.
3 years of experience in clinical research and/or clinical IT systems (i.e STARLIMS Life Sciences)
3 years in Business Analysis within regulated (GxP) environments.
PREFERRED QUALIFICATIONS
Master’s degree (MBA, MS, MPH, MHA) preferred.
CBAP, PMI-PBA, PMP, or Agile certifications.
Experience in global clinical trial environments.
Knowledge of CDISC, SDTM, and clinical data standards.
Experience with reporting tools (Power BI, Tableau, Qlik, Other).Familiarity with cloud-based clinical systems (e.g., Veeva, Medidata, Oracle Clinical, BioClinical, etc.).
Strong understanding of the lab clinical trial lifecycle.
Hands-on experience with LIMS/LIS clinical platforms (i.e STARLIMS Life Sciences)
Experience with system validation and regulatory compliance.
Familiarity with system integrations and data workflows.
Strong analytical and systems-thinking mindset
Technical fluency in enterprise applications
Regulatory compliance expertise
Cross-functional leadership
Vendor management skills
Excellent communication and documentation skills
EDUCATION:
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.
PAY RANGE:
$100,000.00 - $130,000.00
CITY:
Rochester
POSTAL CODE:
14624
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
Apply To This Job