Specialists, Clinical Data Management

Primary Activities (Responsibilities)

• Design, build, maintain, test, and document data review based on specifications from Global Clinical Data Management, Clinical Research, and Global Safety.
• Review technical feasibility of proposed study programming/reporting; implement solutions and coordinate across teams while aligning to protocol.
• Support development and reporting for data cleaning, medical review, clinical monitoring, and safety reports for timely, quality delivery.
• Provide ongoing support for In-Life Reports.
• Ensure Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
• Participate in study improvement initiatives (e.g., automation, system testing, training, and mentoring).

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

• Proficiency in Clinical Data Management/Reporting tools (Databricks, Python, SAS, SQL/PLSQL, Power BI, etc.) and AI tools.
• Knowledge of MS Windows/Office and exposure to web-based applications.
• Knowledge of System Development Lifecycle Management / system validation.
• Strong communication, organization, problem-solving; ability to multi-task and work independently; establish cross-functional relationships.
• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH.