Director, EDC Programming

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Description:

The Director of EDC (Electronic Data Capture) Programming will reside within the Clinical Data Operations function and will be the Global Head the 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 and supplemental packages such as migration review and reporting tools. You will also be accountable for all aspects of Clinical Coding.
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 be accountable for Medidata-related project management, business development, and financial management. 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 provide direction for the continued development and enforcement of data collection standards through updates to Jazz’s Global Library (GLIB) specifications. You will lead a team of EDC Programming professionals, contractors, vendors, and FSPs. You will facilitate effective internal and external relationships. You will be expected to contribute extensively to developing and growing the Clinical Data Operations group within the Global Clinical Development Operations organisation.

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.

Essential Functions

• Responsible for providing leadership, structure, and strategy for the EDC business segment to meet Jazz’s R&D and GCDO EDC related goals and objectives.
• Serve as Business Process Owner (BPO) for the Jazz Medidata URL, Veeva CDMS , IRT,eCOA and develop and lead the execution of strategic plans and objectives for the Jazz URL/EDC and other data capture systems and platforms, concerning data capture and quality; liaise with IT groups to ensure that the platform is developed and implemented in alignment with GCDO business processes.
• Oversees the development and improvements to the core configurations of Jazz’s Medidata Rave URL, Veeva CDMS URL, IRT and eCOA.
• Oversight and liaison with vendors holding Jazz’s additional URLs (including, but not limited to, fostering relationships, participating in the vendors’ URL risk assessments, overseeing any enhancements, monitoring performance, and troubleshooting).
• Responsible for Jazz’s URL and Medidata Rave user and site administration and security, as well as study level archival activities.
• Contribute to strategic planning to ensure optimized use of EDC Programming resources within the area of responsibility. Provide vision, leadership, and mentoring to staff assigned to his/her line management.
• Provides selection, management, leadership and oversight of EDC Programming related CRO(s).
• Primary contact with Medidata (project management, business development, budget and contract development, and invoice approval). Establishes and assures adherence to budgets, schedule, work plans, and performance requirements.
• Participate in the generation and approval of EDC vendor budgets and timelines.
• Oversee all aspects of Clinical Coding. The Manager, Clinical Coding and associated Clinical Coders reports to the Director, EDC Programming
• Participates in the maintenance and continued development of electronic data capture (EDC) standards through updates to Jazz’s Global Library (GLIB) specifications (core, therapeutic area specific and eCOA) electronic Case Report Forms (eCRFs), cross-form and cross-visit edit checks, custom functions, and EDC reporting.
• Supports data standards implementation by ensuring technical quality/system compliance, alignment to industry standards (e.g., CDISC) and regulatory guidance, consistency in adopting data standards across vendors, and support study teams during data standards adoption and implementation.
• Partners with the Lead Clinical Data Managers and other study team members to plan for the success of EDC related study deliverables, such as study EDC builds and EDC migrations in Medidata Rave.
• Serve as a member of the Clinical Data Operations Leadership Team
• Serves as a member of the Data Standards Committee.
• Serve as liaison with the Jazz CDI (Clinical Data Factory) and Jazz Clinical Insights (JCI), and contribute to the execution of strategic plans and objectives for the Jazz CDF, concerning data review and trial management; liaise with IT groups to ensure that the platform is developed and implemented in alignment with GCDO business processes
• Coordinate closely with Clinical Data Management, Clinical Data Innovations, IT, Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence of EDC Programming deliverables.
• Tracks and provides feedback on standard EDC report enhancements.
• Partakes in the development and/or advancement of other data capture technologies in line with Jazz’s standardization goals and initiatives.
• Remains apprised of changing industry regulations and CDISC versions and assesses the impact on the core standards.
• Advises on EDC system improvements to increase efficiency and quality within the EDC business.
• Establishes and manages EDC related operational plans, objectives, priorities and activities.
• Develops and refines EDC related SOPs, Work Practices, and Manuals.
• Oversees RSG at Jazz. Provides specifications and creation of scripts to facilitate electronic safety reporting (setting up and/or repointing of Rave Safety Gateway (RSG). Supports the validation of RSG.
• Supports regulatory submissions and/or inspections as EDC subject matter expert, when needed.
• Ensure that the EDC Programming component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required
• Other duties as assigned.

Required Knowledge, Skills, and Abilities

• 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, and their contributions to the EDC design and EDC study build process
• 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, preferably using Medidata Rave, as an EDC programmer within Clinical Data Management or SAS programmer.
• 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 and integrations of data capture 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, with a high ability to communicate standards-related issues, options, and their impact on study teams.
• Experience representing EDC Programming in regulatory and/or internal inspections preferred
• Travel may be required.

Required/Preferred Education and Licenses

• 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, with demonstrated experience using Medidata Rave from a front-end data management user perspective and back-end user of Medidata Rave, is required.
• 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).

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is:

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html