Director, EDC Programming

Jazz Pharmaceuticals•US - Home-Based - PA, PA

3d•$192,000 - $288,000•Remote

About The Position

The Director of EDC Programming is the global head of EDC Programming within Clinical Data Operations. The role provides leadership, structure, and strategy for the EDC business segment and is accountable for developing accurate, high-quality clinical EDC databases, supporting functional tasks, and providing technical expertise across therapeutic areas and development programs. The Director serves as a subject matter expert and business process owner for core data capture systems and platforms, including Medidata Rave, Veeva CDMS, IRT, and eCOA, and oversees their administration, configurations, integrations, security, and ongoing improvements. The position leads EDC programming staff, contractors, vendors, and functional service providers; oversees EDC-related CROs and vendor relationships; and manages Medidata-related projects, budgets, contracts, schedules, and performance. The Director advances data collection and EDC standards through Jazz’s Global Library specifications, eCRFs, edit checks, custom functions, reporting, procedures, and templates. The role also oversees Clinical Coding and collaborates broadly across Clinical Data Operations, IT, Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory. The Director supports study EDC builds and migrations, data standards adoption, regulatory submissions and inspections, and the maintenance of required trial documentation. The role monitors changing regulations and CDISC standards, advises on system improvements, and contributes to the growth and strategic development of the Clinical Data Operations organization. Travel may be required.

Requirements

Bachelor’s degree in computer science or a science-related discipline.
Extensive relevant pharmaceutical or CRO experience in an FDA-regulated environment.
Demonstrated experience using Medidata Rave from both 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, and data management in drug development.
Understanding of other functions involved in clinical trial execution and their contributions to EDC design and study builds.
Experience across all stages of clinical trials and with 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 and with CRF design, query resolution, data validation, data integration, data coding, targeted SDV, and RSG setup and maintenance; preferably using Medidata Rave as an EDC programmer within Clinical Data Management or as a SAS programmer.
Advanced knowledge of EDC systems, their data structures, and integrations among data capture systems.
Understanding of clinical coding requirements within clinical studies.
Experience working with globally distributed teams.
Ability to solve complex problems and prioritize and handle multiple tasks simultaneously.
Effective leadership skills and demonstrated ability to foster team productivity and cohesiveness.
Leadership experience and ability to hire and develop staff.
Strong communication, interpersonal, organizational, project management, and problem-solving abilities.
Excellent written and verbal communication skills, including the ability to explain standards-related issues, options, and impacts to study teams.
Knowledge of FDA/ICH guidelines and industry-standard practices for managing clinical trial data.
Working knowledge of FDA guidance documents on computerized systems used in clinical trials and general principles of software validation.
Working knowledge of 21 C.F.R. Part 11 and CDISC standards, including CDASH, SDTM, data mapping specifications, and annotated CRFs.

Nice To Haves

An advanced degree.
Experience with a Metadata Repository or related standards management system.
Experience representing EDC Programming in regulatory and/or internal inspections.

Responsibilities

Provide leadership, structure, and strategy for the EDC business segment to meet R&D and GCDO goals and objectives.
Serve as Business Process Owner for Jazz’s Medidata URL, Veeva CDMS, IRT, and eCOA, and lead strategic plans for data capture systems and platforms.
Oversee development and improvements to the core configurations of Jazz’s Medidata Rave URL, Veeva CDMS URL, IRT, and eCOA.
Oversee vendor relationships for additional Jazz URLs, including risk assessments, enhancements, performance monitoring, and troubleshooting.
Manage Jazz URL and Medidata Rave user and site administration, security, and study-level archiving.
Plan EDC Programming resource utilization and provide vision, leadership, and mentoring to direct reports and staff.
Select, manage, lead, and oversee EDC Programming-related CROs.
Serve as the primary contact with Medidata for project management, business development, budgets, contracts, and invoice approval; ensure adherence to budgets, schedules, work plans, and performance requirements.
Participate in generating and approving EDC vendor budgets and timelines.
Oversee all aspects of Clinical Coding.
Maintain and develop EDC standards through updates to Global Library specifications, eCRFs, edit checks, custom functions, and EDC reporting.
Support data standards implementation, technical quality, system compliance, alignment to industry standards and regulatory guidance, consistency across vendors, and study-team adoption.
Partner with Clinical Data Managers and study teams to plan and deliver EDC study builds and migrations in Medidata Rave.
Serve on the Clinical Data Operations Leadership Team and the Data Standards Committee.
Liaise with Clinical Data Factory, Clinical Insights, and IT groups on strategic plans and platform alignment with GCDO business processes.
Coordinate with clinical, data, IT, statistical, safety, project management, and regulatory functions to ensure operational excellence of EDC deliverables.
Track and provide feedback on standard EDC report enhancements.
Contribute to the development and advancement of other data capture technologies consistent with standardization goals.
Monitor industry regulations and CDISC versions and assess their impact on core standards.
Advise on EDC system improvements that increase efficiency and quality.
Establish and manage EDC operational plans, objectives, priorities, and activities.
Develop and refine EDC SOPs, work practices, and manuals.
Oversee RSG, specify and create scripts for electronic safety reporting, and support RSG validation.
Support regulatory submissions and inspections as an EDC subject matter expert when needed.
Ensure the EDC Programming component of the TMF and other submission- and inspection-supporting documentation is maintained to the required standard.
Perform other duties as assigned.