Clinical Data Associate

Role: The Clinical Data Associate is responsible for end-to-end delivery of clinical data sciences for a study, including database build, data acquisition, and management. Objectives: Ensure high-quality data collection, flow, and integrity to support clinical trial success. Responsibilities: oversee data management activities, develop and maintain Data Management Plans, drive data cleaning, manage vendor performance, and ensure compliance with regulatory standards (e.g., FDA, ICH, GCP). Lead data coordination efforts from study start-up to database lock, including milestone tracking, risk management, and process improvements. Serve as a key point of contact for data-related issues and collaborate with cross-functional teams such as statistics, medical, PK, and operations. Qualifications: Master’s in Life Sciences, Informatics, or related technical field; or Bachelor’s plus 3+ years in clinical data management. Skills: experience with clinical data standards, data flow, databases, and programming tools such as SAS, R, Python, Tableau, PowerBI, SQL; knowledge of medical terminology and therapeutic areas. Preferred: Society of Clinical Data Management certification, experience with eCOA systems, and international travel readiness. Work setup: Onsite in Indianapolis, with potential domestic/international travel.