About the role
We are looking for an experienced Clinical Database Programming Associate Manager to support global clinical trials by designing, developing, validating, and maintaining clinical databases. The role involves end-to-end clinical database programming using Medidata Rave, ensuring high-quality database builds, regulatory compliance, and timely study delivery. The candidate should possess strong expertise in clinical database programming, study build, edit check programming, custom functions, post-production changes, database migrations, and database validation while collaborating with cross-functional teams and mentoring junior programmers.
Responsibilities:
- Design, develop, and maintain clinical databases using Medidata Rave.
- Build end-to-end study databases including eCRF design, folder and matrix configuration, edit check programming, custom function development, derivations, and core configuration.
- Develop and review complex edit checks, patient profile listings, preprocessing checks, and validation reports.
- Perform database validation, UAT support, and quality reviews.
- Handle Post Production Changes (PPC), impact assessments, database amendments, and migrations.
- Support database lock activities and resolve critical production issues.
- Review protocol specifications and ensure accurate database implementation.
- Work closely with clinical data management, biostatistics, clinical operations, medical teams, and sponsors.
- Ensure compliance with CDASH, SDTM, ICH-GCP, SOPs, and regulatory standards.
- Perform root cause analysis and implement corrective actions.
- Mentor junior programmers, review deliverables, and provide technical guidance.
- Manage multiple studies while ensuring delivery within project timelines.