Director, EDC Programming

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Provide leadership, structure, and strategic direction for the EDC business segment

• Act as the Business Process Owner for Jazz Medidata URL, Veeva CDMS, IRT, and eCOA

• Drive strategic planning and objectives for EDC and data capture systems

• Supervise the development and enhancements of Medidata Rave, Veeva CDMS, IRT, and eCOA core configurations

• Manage vendor relationships, URL risk assessments, enhancements, performance monitoring, and troubleshooting

• Oversee URL and Medidata Rave user/site administration, security, and study-level archival activities

• Optimize EDC Programming resources and provide mentorship to assigned staff

• Select, manage, and supervise EDC Programming CROs

• Manage Medidata project management, business development, budgets, contracts, and invoices

• Oversee Clinical Coding

• Maintain and enhance EDC standards, Global Library specifications, eCRFs, edit checks, custom functions, and EDC reporting

• Support the implementation of data standards, technical quality, system compliance, CDISC alignment, and regulatory guidance

• Collaborate with clinical data managers and study teams on EDC builds and migrations

• Participate in the Clinical Data Operations Leadership Team and Data Standards Committee

• Liaise with teams from Clinical Data Factory, Clinical Insights, IT, Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory

• Develop EDC reports, data capture technologies, operational plans, SOPs, work practices, and manuals

• Oversee Rave Safety Gateway, including script specifications, setup, repointing, and validation

• Support regulatory submissions and inspections as an EDC subject matter expert

• Maintain EDC Programming documentation for the TMF and regulatory submissions

⛳️ Requirements

• A minimum of a bachelor’s degree in computer science or a science-related field

• Significant pharmaceutical/CRO experience in an FDA-regulated environment

• Proven experience using Medidata Rave from both front-end data management and back-end user perspectives

• Experience in leading an EDC programming team

• Advanced proficiency in SAS and SQL, Crystal Reports, Business Objects, and other business intelligence tools

• Comprehensive knowledge of EDC programming, including EDC, IRT, and eCOA

• Experience in all phases of a clinical trial and vendor oversight

• Experience managing and mentoring EDC programmers

• Familiarity with ICH/GCP guidelines as they pertain to data management

• Understanding of CDISC CDASH and SDTM standards

• Extensive experience managing Medidata and other EDC data vendors

• Significant experience in programming EDC databases, CRF design, query resolution, data validation, data integration, data coding, targeted SDV, and RSG setup/maintenance

• Advanced knowledge of EDC systems, data structures, and integrations

• Understanding of Clinical Coding requirements within clinical studies

• Experience working with globally distributed teams

• Experience representing EDC Programming in regulatory and/or internal inspections is preferred

• Travel may be necessary

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation

• Discretionary equity grants

• Medical insurance

• Dental insurance

• Vision insurance

• 401k retirement savings plan

• Flexible paid vacation

• Remote work arrangement