[Hiring] Director, EDC Programming @Jazz Pharmaceuticals

Role Description

The Director of EDC (Electronic Data Capture) Programming will reside within the Clinical Data Operations function and will be the Global Head of EDC Programming. You will be accountable for developing accurate clinical EDC databases with high quality, supporting all functional tasks and providing technical expertise across therapeutic areas or development programs. You will provide application administration and technical support as the subject matter expert on core business packages, including but not limited to:

• iMedidata
• Classic Rave
• Rave EDC
• BO4
• TSDV
• Coder
• CTMS
• RSG
• Veeva CDMS
• IRT eCOA
• DCT
• Supplemental packages such as migration review and reporting tools

You will oversee and be responsible for the development and enhancements to Jazz’s Medidata Rave URL core configurations and Jazz’s CRO URLs. You will ensure that EDC-related standards are used on all studies where possible, resulting in measurable efficiency gains. You will provide direction with data standards-related projects and cross-functional data standards initiatives requiring strong attention to detail, project management, and development of standards process documents and templates.

You will lead a team of EDC Programming professionals, contractors, vendors, and FSPs, facilitating effective internal and external relationships. You will fulfill the following essential functions and may also be assigned to other senior duties as assigned by the Head of Clinical Data Operations.

Qualifications

• Thorough knowledge of EDC programming (EDC, IRT, eCOA) and Data Management and its role in the drug development process
• Understanding of the contributions of other functions critical to the execution of clinical trials
• Experience in all stages of a clinical trial and vendor oversight
• Experience in managing and mentoring EDC programmers
• Demonstrated 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
• Must be able to demonstrate extensive experience in programming EDC databases, CRF design, query resolution, data validation, data integration, data coding, targeted SDV, and RSG setup/maintenance
• Experience with a Metadata Repository or related standards management system is a plus
• Advanced knowledge of EDC systems and of data structures within these systems
• Understanding of the Clinical Coding requirements within Clinical Studies
• Experience working with a globally distributed team
• Ability to work on and solve complex problems
• Ability to prioritize and handle multiple tasks simultaneously
• Effective leadership skills and proven ability to foster team productivity and cohesiveness
• Solid leadership experience and the ability to hire and develop staff
• Excellent communication/interaction skills and experience in a dynamic and growing organization
• Must be a team player with strong interpersonal, organizational, project management, and problem-solving abilities
• Excellent written and verbal communication skills
• Experience representing EDC Programming in regulatory and/or internal inspections preferred

Requirements

• A minimum of a bachelor’s degree in computer science or a science-related discipline is required
• An advanced degree is preferred
• Extensive relative pharmaceutical/CRO experience in an FDA-regulated environment
• Experience leading an EDC programming associated Team
• Advanced experience using SAS and SQL, Crystal Reports, Business Objects, and other business intelligence tools is required
• Knowledge of FDA/ICH guidelines and industry standard practices regarding managing clinical trial data
• Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation
• Working knowledge of 21 C.F.R. Part 11 and CDISC Standards (CDASH, SDTM, and the creation of data mapping specifications and annotated CRFs)

Benefits

• Medical, dental and vision insurance
• 401k retirement savings plan
• Flexible paid vacation