Director, EDC Programming

Jazz Pharmaceuticals

. Provide leadership, structure, and strategy for the EDC business segment .

Posted 11/6/2026full-timeRemote • Pennsylvania • United States, United KingdomLead💰 $192,000 - $288,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in EDC programming, including Medidata Rave, IRT, and eCOA, while providing leadership and strategic direction for clinical data management. Proficient in managing vendor relationships, regulatory compliance, and optimizing data capture technologies within an FDA-regulated environment.

Highest-signal resume keywords

EDC Programming LeadershipMedidata Rave ExpertiseSAS and SQL ProficiencyClinical Trial ManagementCDISC CDASH and SDTM Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

EDC ProgrammingMedidata RaveSASSQLCrystal ReportsBusiness ObjectsClinical CodingData ValidationData IntegrationQuery Resolution

Soft Skills

MentoringLeadershipCollaborationCommunicationProblem-Solving

Tools & Technologies

Veeva CDMSIRTECOAEDC SystemsData Capture Technologies

Industry Keywords

FDA-Regulated EnvironmentICH/GCP GuidelinesClinical TrialsCRO ExperienceRegulatory Submissions

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Provide leadership, structure, and strategy for the EDC business segment
Serve as Business Process Owner for Jazz Medidata URL, Veeva CDMS, IRT, and eCOA
Lead strategic plans and objectives for EDC and data capture systems
Oversee development and improvements to Medidata Rave, Veeva CDMS, IRT, and eCOA core configurations
Manage vendor relationships, URL risk assessments, enhancements, performance monitoring, and troubleshooting
Manage URL and Medidata Rave user/site administration, security, and study-level archival activities
Optimize EDC Programming resources and mentor assigned staff
Select, manage, and oversee EDC Programming CROs
Manage Medidata project management, business development, budgets, contracts, and invoices
Oversee Clinical Coding
Maintain and develop EDC standards, Global Library specifications, eCRFs, edit checks, custom functions, and EDC reporting
Support data standards implementation, technical quality, system compliance, CDISC alignment, and regulatory guidance
Partner with clinical data managers and study teams on EDC builds and migrations
Serve on the Clinical Data Operations Leadership Team and Data Standards Committee
Liaise with Clinical Data Factory, Clinical Insights, IT, Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory teams
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

What you’ll need

Minimum of a bachelor’s degree in computer science or a science-related discipline
Extensive pharmaceutical/CRO experience in an FDA-regulated environment
Demonstrated experience using Medidata Rave from front-end data management and back-end user perspectives
Experience leading an EDC programming team
Advanced experience using SAS and SQL, Crystal Reports, Business Objects, and other business intelligence tools
Thorough knowledge of EDC programming, including EDC, IRT, and eCOA
Experience in all stages of a clinical trial and vendor oversight
Experience managing and mentoring EDC programmers
Knowledge of ICH/GCP guidelines as they relate to data management
Understanding of CDISC CDASH and SDTM standards
Extensive experience managing Medidata and other EDC data vendors
Extensive experience 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 preferred
Travel may be required

Benefits

Comp & perks

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