Manager, EDC Database Programming

Job title: Manager, EDC Database Programming

About the Role The Manager, EDC Database Programming serves as a subject matter expert for oversight, guidance, and design of study build activities for all clinical studies using Electronic Data Capture (EDC) systems and related technologies, including Clinical Data Programming and Reporting. The role owns and oversees study design, build, edit checks, and custom function programming; reviews CRF specifications and Data Validation Specifications (DVS). It also supports functional and user acceptance testing, and manages quality deliverables in partnership with the RAVE Administrator, Study Data Managers, and service providers. The role will engage in governance and advancement of DS Global Library Standards and collaborates closely with Biostatistics and Data Management, external CROs, service providers, and stakeholders.

What You'll Do

• Provide guidance, direction, and accountability for study build activities to ensure high quality, consistency, and adherence to eCRF specifications.
• Manage all study build deliverables for timely, high-quality builds across studies, conforming to DS standards and eCRF specs.
• Manage administrative and operational deliverables, timelines pertaining to study build activities, edit check programming, and custom function development - including proactive review, testing, and supporting documentation to ensure high quality study builds for all studies.
• Collaborate with the study data managers, external CROs, and service providers to ensure study build configuration is reviewed, tested, and completed with high quality in a timely manner.
• Guide the operational execution of the steps and procedures for consistency and accuracy pertaining to the delivery of high-quality study builds for all studies.
• Proactively identify and resolve issues that may influence and/or impact study build quality and other deliverables.
• Serve as a subject matter expert and provide oversight, guidance, and design of study build activities for all studies; establish design specifications of study build activities including core configuration, eCRFs, DVS, and Reporting; establish and confirm the configuration of the EDC study build in conformance with study design specifications for eCRFs, DVS, Custom Functions, tSDV, RAVE Safety Gateway, Integrations, and Reporting; establish and implement edit check and custom functions programming standards.
• Review and provide input to quality database designs for fit and feasibility within the EDC application and ensure consistency with established standards; ensure system interfaces are designed and configured for optimal use and not in conflict with the study build and relevant specifications for all studies.
• Lead and/or provide oversight to functional and user acceptance testing activities including edit check and custom function test scripts, programming, and validation tasks; CRF screens for the study conforms to the CRF specifications, and configuration.
• Lead and/or provide oversight on the impact analysis and risk assessment of study build change requests, maintain documentation, and facilitate the implementation of changes as per the change control procedures.
• Track, debug, and resolve issues pertaining to study build and programming tasks for all studies.
• Operational Efficiency/ Continuous Improvement: Identify opportunities for continuous process improvements, improve work procedures, QC procedures, checklists to track milestones, status, and issues; ensure traceability, and study build performance metrics.
• Contribute to the development of content and training pertaining to all aspects of the study build activities in partnership with the study data managers and the functional service provider(s).

What We're Looking For

• Education: Bachelor's Degree in Life Sciences or related field required; Master's Degree preferred.
• Experience: Minimum of 5 years of EDC study build and database programming experience and data validation programming in the device/pharmaceutical/CRO industry.
• Expertise: Required expertise in Clinical Programming, methods, and techniques.
• Knowledge: Knowledge of CTMS, EDC, Clinical Data Repository (CDR); CDASH and CDISC data standards; data acquisition and integration tools and technologies.
• Collaboration: Ability to work with people at different levels of experience, different disciplines, and cultures; Self-directed; able to work independently; Strong communication, negotiation, and conflict resolution skills; Ability to manage multiple priorities; Strong background in Clinical Programming, Project Management, and data acquisition methods.