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  for more information.

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.

• 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…