Clinical Data Programming

Job Purpose

• The incumbent manages Clinical Data Programming to ensure timely creation, validation, testing, implementation and maintenance of databases required across all assigned projects.
• Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance to the study Protocol, DMP, SOP and all applicable regulatory requirements and standards.
  
  

• Deploy complete, accurate, and efficient clinical study databases to support Data Management and data processing activities.
• Facilitate the preparation, transfer, and integration of clinical data from internal and external sources into study databases. Deliver clinical study data in various formats to key stakeholders as needed.
• Ensure high-quality deliverables and foster strong collaboration with internal and external stakeholders. Actively participate in project teams to develop and maintain programs aligned with project standards.
• Manage data exchange with external stakeholders (e.g., labs, ECG vendors, Safety/IDMCs) as required.
• Provide ongoing end-user support to project teams to ensure systems and programs function correctly and efficiently.
• Set up and support data review and reporting tools for DM stakeholders, including SAS programmers, Clinical, Medical, Pharmacovigilance, and Regulatory Affairs, and the Study Management Team.
• Offer technical expertise and programming support to projects and data management staff.
• Communicate project status and key issues to DM Management.
• Contribute to the development of new data systems programming procedures and processes.
• Stay current with technological advancements and collaborate with Global Training and IT teams to maximize their application in data management.
• Mentor and train team members while assisting in work delegation.
• Support and maintain standardization of CRF/eCRF modules, data quality rules, data structures, libraries, code lists, and dictionaries in line with CDISC standards.
• Participate in evaluating external vendors and technologies for alignment with project goals and quality standards.
• Identify opportunities for process improvement through standardization and technology to enhance efficiency, quality, and timeliness of deliverables.
  
  

• Strong proficiency in Power BI, R, and/or SAS for programming data listings, KRI visuals, and developing impactful visualizations that aid cross-functional teams (e.g., Medical Monitors, Biostatisticians) in drawing meaningful inferences.
• Ability to build analytical models, generate reports, and design dashboards tailored to business requirements.
• Experience in working with dashboards integrating multiple data sources (Excel, TXT, Oracle, SAS) using tools like Power BI and SAS.
• Develop listings and respond to ad-hoc requests by producing tables based on supplied shells, and support edit checks, patient profiles, protocol deviations, coding reports, and other data analysis requirements.
  
  

• Preferably a minimum of a Bachelors degree in a Life Science, Computer Science or related discipline.
• Minimum 8-10 years of clinical data programming experience including working knowledge using clinical data programming tools and applications.
• Experience of leading clinical programming effort across global clinical studies is preferred.