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.
Key Roles and Responsibilities
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.
Qualification, Skill and Competencies Requirements
Preferably a minimum of a Bachelor's 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.
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