Senior Clinical Trials IT Business Analyst

🕒 May 18

🗽 New York – Remote

🗽 New York – Remote

💵 $100k - $130k / year

⏰ Full Time

🟠 Senior

🧐 Business Analyst

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ACM Global Laboratories

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ACM Global Laboratories is a leading provider of clinical trial testing services, supporting clinical trials globally in over 65 countries. The company offers a range of bioanalytical services, including small and large molecule analysis, biomarker analysis, and various laboratory testing solutions such as routine safety testing, flow cytometry, and advanced sample tracking. ACM Global Laboratories is recognized for its expertise in bioanalysis and toxicology services, ensuring high sensitivity and accuracy in drug and metabolite measurements across diverse biological samples. The company is dedicated to delivering actionable clinical insights and reliable toxicology services to healthcare providers, partnering with clinical trials to optimize development projects through state-of-the-art laboratory services, specimen management, and global logistics.

📋 Description

• Serve as a strategic liaison between Clinical Development and Information Technology. • Lead the analysis, design, implementation, and optimization of clinical trial technology solutions supporting global clinical research operations. • Obtain, analyze, and document business, functional, and technical requirements. • Translate clinical and non-clinical operational needs into system configurations and technical solutions. • Develop 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. • Lead or support implementation, upgrades, enhancements, optimization, and maintenance of LIMS, LIS, Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks, and Validation Lifecycle Management systems. • Configure and support system enhancements; coordinate vendors and technical solution delivery. • Support change request management and release management processes. • Support CSV/CSA activities, validation plans, risk assessments, IQ/OQ/PQ testing, and validation documentation. • Ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, and MOH requirements. • Participate in audit and inspection readiness efforts. • Collaborate on APIs, HL7, middleware, data integrity, data migration, master data governance, reconciliation, and reporting requirements. • Lead UAT, develop test scripts, coordinate execution, manage defect tracking and resolution, support regression testing and release validation. • Facilitate deployment and post-go-live support. • 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.

🎯 Requirements

• 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. • 3 years in Business Analysis within regulated (GxP) environments. • Sedentary work capability: exerting up to 10 pounds of force occasionally. • Preferred: Master’s degree (MBA, MS, MPH, MHA). • Preferred: CBAP, PMI-PBA, PMP, or Agile certifications. • Preferred: Experience in global clinical trial environments. • Preferred: Knowledge of CDISC, SDTM, and clinical data standards. • Preferred: Experience with reporting tools such as Power BI, Tableau, or Qlik. • Preferred: Familiarity with cloud-based clinical systems such as Veeva, Medidata, Oracle Clinical, or BioClinical. • Preferred: Strong understanding of the lab clinical trial lifecycle. • Preferred: Hands-on experience with LIMS/LIS clinical platforms. • Preferred: Experience with system validation and regulatory compliance. • Preferred: Familiarity with system integrations and data workflows. • Preferred: Technical fluency in enterprise applications. • Preferred: Regulatory compliance expertise. • Preferred: Cross-functional leadership. • Preferred: Vendor management skills. • Preferred: Excellent communication and documentation skills.