Clinical Data & Applications Manager
$143,000–$169,000 year
Hybrid · King of Prussia, Pennsylvania, United States
Job Summary
The Clinical Data & Applications Manager leads governance, validation, and delivery of clinical data artifacts to CSL Behring’s programs, applying CDASH/SDTM mapping, eCRF design, and EDC expertise (Medidata Rave, Veeva Vault) to ensure data quality and regulatory compliance. S/he collaborates with Statistics, Data Management, and Standards to define and enforce data quality criteria, validation rules, and reusable reporting libraries across in-house, hybrid, and vendor-supported studies. Responsibilities include overseeing data quality control frameworks, vendor artifact review, data visualization and reporting development, and contributing to scalable data platforms and AI-enabled automation initiatives. Requires 5+ years in clinical data management, strong CDISC/CDASH/SDTM experience, proficiency with EDC systems, and the ability to operate in a hybrid on-site work environment in King of Prussia, PA. The role emphasizes cross-functional collaboration, data integration strategies, and adherence to regulatory standards for submission readiness; base salary range is $143,000–$169,000 with potential additional compensation.
Required Qualifications
- BSc in Computer Science, Mathematics, Statistics or related area
- 5+ years of clinical data management or related experience in pharma/CRO environments
- Strong working knowledge of CDISC standards, especially CDASH and SDTM
- Practical experience in data mapping, validation, and submission readiness
- Proficiency with EDC systems (e.g., Medidata Rave, Veeva Vault) and understanding of eCRF design
- Experience overseeing data quality frameworks, validation rules, and vendor deliverables
- Ability to develop and maintain reports and listings for study teams; data visualization and reporting skills
- Strong communication and organizational skills; ability to work in a matrix environment
- Fluent in English; able to collaborate across cross-functional teams
- Proficiency in SAS; familiarity with Python, R, or C# is a plus
- Awareness of regulatory standards and submission readiness including SDTM
- Ability to support data governance initiatives and scalable data platforms
- Knowledge of define.xml and external data sources integration
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