Specialists, Clinical Data Management

Primary Responsibilities:

• Design, build, maintain, test, and document data review based on written specifications.
• Review technical feasibility of study-team proposed programming/reporting and technically implement; collaborate across teams and communicate issues/ideas while understanding protocol.
• Support development and reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability.
• Provide ongoing support for In-Life Reports.
• Ensure Change Requests and Incident Reports are documented, signed off, tracked, and reported to upper management.
• Participate in study improvement initiatives (e.g., automation), testing of new systems, and ongoing training/mentoring.

• Associate degree + 3+ years in clinical data programming/data engineering or related functions, OR
• Bachelor’s degree + 2+ years in related clinical data programming/data engineering/clinical operations functions, OR
• Advanced degree preferred (master’s/doctorate) with experience in clinical development and/or related activities.

• Proficiency in clinical data/reporting systems (e.g., Databricks, Python, SAS, SQL/PL/SQL, Power BI) and AI tools.
• MS Windows/Office knowledge; exposure to web-based applications.
• System Development Lifecycle Management/system validation knowledge.
• Strong relationships, urgency/customer focus, communication with study teams, organization/problem-solving, ability to learn, multitask and work independently.
• Understanding of drug discovery process, FDA regulations, GxP, and ICH.

• Clinical Data Management, Communication, Programming, Data Analysis/Quality Assurance, EDC, PL/SQL, SQL databases, team communication.

• comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.