Pozent Corporation · 12 hours ago
Clinical BA
South Plainfield, NJ
Contract
Onsite
Senior Level
5+ years expPozent Corporation is a company focused on clinical operations, and they are seeking a Clinical Business Analyst to lead business analysis activities across the clinical trial lifecycle. The role involves collaborating with various teams to define processes, translate needs into technical designs, and ensure compliance with clinical data standards.
AnalyticsAppsArtificial Intelligence (AI)BlockchainDeveloper APIsEthereumInformation TechnologyMachine Learning
Responsibilities
Led business analysis activities across end-to-end clinical trial lifecycle including study start-up, data management, safety/pharmacovigilance, and regulatory submissions
Partnered with Clinical Operations, Data Management, Medical Affairs, and Regulatory teams to define business processes, functional specifications, and system requirements
Acted as a bridge between business and IT, translating scientific and operational needs into technical designs for clinical systems and data platforms
Supported implementation, enhancement, and optimization of clinical systems such as EDC, CTMS, eTMF, RTSM/IWRS, and safety databases
Drove adoption of clinical data standards including CDISC (SDTM, ADaM, CDASH) and ensured compliance with ICH-GCP, FDA, EMA regulations
Led requirements gathering, gap analysis, UAT planning/execution, and post-implementation support across multiple global studies
Collaborated with CROs, vendors, and internal stakeholders to ensure timely and high-quality delivery of clinical technology solutions
Applied Agile and SDLC methodologies to deliver projects on time and within scope while improving process efficiency and data quality
Provided mentoring and guidance to junior business analysts and cross-functional teams
Qualification
Required
Led business analysis activities across end-to-end clinical trial lifecycle including study start-up, data management, safety/pharmacovigilance, and regulatory submissions
Partnered with Clinical Operations, Data Management, Medical Affairs, and Regulatory teams to define business processes, functional specifications, and system requirements
Acted as a bridge between business and IT, translating scientific and operational needs into technical designs for clinical systems and data platforms
Supported implementation, enhancement, and optimization of clinical systems such as EDC, CTMS, eTMF, RTSM/IWRS, and safety databases
Drove adoption of clinical data standards including CDISC (SDTM, ADaM, CDASH) and ensured compliance with ICH-GCP, FDA, EMA regulations
Led requirements gathering, gap analysis, UAT planning/execution, and post-implementation support across multiple global studies
Collaborated with CROs, vendors, and internal stakeholders to ensure timely and high-quality delivery of clinical technology solutions
Applied Agile and SDLC methodologies to deliver projects on time and within scope while improving process efficiency and data quality
Provided mentoring and guidance to junior business analysts and cross-functional teams
Clinical Trial Operations & R&D
Business & Functional Requirements
Clinical Systems (EDC, CTMS, eTMF, Safety)
Clinical Data Standards (CDISC, SDTM, ADaM)
Regulatory Compliance (ICH-GCP, FDA, EMA)
Agile / SDLC / UAT
Stakeholder & Vendor Management
Company
Pozent Corporation
POZENT is a digital technology and workforce solutions company with expertise in Digital Artificial Intelligence & Block Chain technologies.
51-200 employees
H1B Sponsorship
Pozent Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (6)
2023 (17)
2022 (15)
2021 (13)
2020 (7)
Funding
Current Stage
Growth StageCompany data provided by crunchbase