Senior Clinical Data Associate

🕒 May 26

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Sumitomo Pharma America, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

📋 Description

• Perform end to end clinical data review activities, including query generation, review, follow up, and closure, in accordance with study specific guidelines and timelines • Conduct in house data review and provide detailed feedback to the Lead/Clinical Data Manager or CRO Data Management team • Support eCRF design, system validation activities, and ongoing EDC updates in collaboration with external vendors • Assist in the development, review, and maintenance of Data Management documentation, including: Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications / edit checks, Data Cleaning and Reconciliation Plans • Perform reconciliation activities (e.g., SAE reconciliation), raise and track associated queries, and escalate potential issues to Safety and Data Management leadership • Support interim analysis and database lock activities, including focused data cleaning and reconciliation deliverables • Support management of Lab Normal Ranges for studies with Local Labs • Provide data management status updates to internal study teams in the absence of the Lead/Clinical Data Manager • Take ownership of defined data management tasks or act as the primary Data Management contact for selected projects or study components • Train and mentor junior Clinical Data Associates on assigned tasks and Data Management procedures • Ensure strict adherence to Data Management standards, SOPs, and applicable regulatory requirements • Perform other assigned duties in support of departmental objectives

🎯 Requirements

• Bachelor’s degree in life sciences or a related field required • Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry • Oncology experience preferred • Ability to travel

🏖️ Benefits

• Merit-based salary increases • Short incentive plan participation • Eligibility for 401(k) plan • Medical, dental, vision, life, and disability insurances • Flexible paid time off • 11 paid holidays • Additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter