Senior Clinical Trials IT Business Analyst
Rochester Regional Health · Rochester, NY · 1 mo ago
Information Technology$100k–$130k/yrFull-time
Repsonsibilities
- Business & Technical Analysis
- Systems Implementation & Lifecycle Management
- Validation & Compliance (GxP)
- Integration & Data Management
- Testing & Deployment
- Stakeholder & Project Engagement
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.
- 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.
Pay
$100,000.00 - $130,000.00