Manager, Database Management Systems
Job Summary
Seeking an experienced clinical data professional to lead database management and clinical data standards activities supporting global clinical trials. This role will serve as a subject matter expert in clinical data standards, Medidata Rave global library development, and SAS programming, partnering with cross-functional teams to ensure high-quality, standardized clinical data collection and reporting.
Key Responsibilities
- Lead development and maintenance of global clinical data standards, including CDISC-compliant operational data mappings and SDTM standards.
- Build and maintain Medidata Rave global library objects, including eCRFs, edit checks, and CRF Completion Guidelines.
- Develop SAS programs for edit checks, data imports, listings, custom reports, and clinical data validation.
- Create and manage clinical datasets from raw data using Base SAS, Advanced SAS, Macros, PROC SQL, and SAS ODS.
- Support CRF design, annotated CRFs, data mapping specifications, and define.xml requirements.
- Collaborate with Clinical Data Management, Clinical Operations, EDC Programming, vendors, and CRO partners to ensure consistent standards implementation.
- Drive process improvements, support governance committees, and provide mentorship to junior team members.
- Ensure compliance with CDISC standards, GCP, ICH guidelines, and regulatory requirements.
Required Qualifications
- Strong clinical domain knowledge with a solid understanding of clinical trial phases.
- Prior work experience must be within the clinical research, pharmaceutical, biotechnology, healthcare, or CRO industry.
- Hands-on experience programming Edit Check Listings using SAS.
- Experience with Data Import Programming using SAS.
- Experience utilizing SAS Output Delivery System (ODS) to generate reports in RTF, PDF, and HTML formats.
- Experience reading raw data files, creating data structures, handling missing values, troubleshooting programming errors, and managing clinical data.
- Experience appending and concatenating SAS datasets.
- Proficiency developing reports using PROC PRINT, PROC FREQ, PROC MEANS, PROC TRANSPOSE, and PROC SQL.
- Strong programming experience with SAS Macros and SQL.
- Experience creating SAS datasets from raw clinical data, including status and efficacy datasets.
- Ability to develop project-specific macros and formats, load client data from external platforms, and prepare datasets for client delivery.
- Experience creating clinical listings and custom reports based on business requirements.
- Knowledge of Vendor Import Programming.
- Strong technical expertise in Base SAS, Advanced SAS, SAS Macros, SAS SQL, and SAS Grid.
- Ability to develop code using Base SAS programs, SAS procedures, and standardized macros.
- Excellent written and verbal communication skills.
Preferred Qualifications
- Experience with CDASH and ADaM standards.
- Extensive Medidata Rave global library development experience.
- Knowledge of MedDRA, WHODrug, annotated CRFs, and data mapping specifications.
- Experience with Veeva, Medrio, Oracle Clinical, TrialGrid, or similar EDC systems.
- Demonstrated ability to lead cross-functional initiatives in a global clinical development environment.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $84,600.00 - $211,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.