Clinical Database Programming Associate - Rave

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.

Skills

Medidata Rave, Rave, derivations, eCRF, edit checks, migrations, validation