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Associate Director, Electronic Data Capture Programming

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: July 17, 2021

Job Description:

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

The Associate Director, EDC (Electronic Data Capture) Programming will reside within Clinical Data Management department and provide direction and management for the continued development and enforcement of data collection standards through updates to Jazz’s Global Library specifications, and serves as an interface between Clinical Data Management, Clinical Data innovations, IT, and other functional groups as needed. S/he will be responsible for developing accurate clinical EDC databases, with a high degree of quality, support all functional tasks and provides technical expertise across therapeutic areas or development programs. S/he 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, CTMS, RSG and supplemental packages such as migration review and reporting tools.
S/he may lead a team of EDC Programming professionals, contractors, vendors and FSPs. S/he will facilitate effective internal and external relationships. S/he will be expected to contribute extensively to the development and growth of the Clinical Data Management group within the Global Clinical Development Operations organization.

S/he will oversee and be responsible for the development and enhancements to Jazz’s Medidata Rave URL core configurations, as well as Jazz’s vendor URLs. S/he will be responsible for Medidata related project management, business development, and financial management. S/he will be responsible for ensuring that EDC related standards are used on all studies where possible, resulting in measurable efficiency gains. S/he 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.

Essential Functions:

  • Responsible for providing leadership, structure and vision for the EDC business segment to meet Jazz’s Clinical Data Management EDC related goals and objectives.
  • Oversees the development and improvements to the core configurations of Jazz’s Medidata Rave URL.
  • 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 budgets and timelines
  • Manages the maintenance and continued development of electronic data capture (EDC) standards through updates to Jazz’s Global Library (GLIB) specifications (core and therapeutic area specific) 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 the adoption of data standards across vendors, and provides support for study teams during data standards adoption and implementation.
  • Partners with the Lead Clinical Data Managers and other study team members to plan for success of EDC related study deliverables, such as study EDC builds and EDC migrations in Medidata Rave.
  • Partners with the Clinical Data Innovations (CDI) unit to ensures appropriate methods are used for reporting, metrics and analytics.
  • Serves as a member on the Data Standards Committee.
  • 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.
  • 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.
  • Assists in formalizing and assessing quality of the standards governance plan.
  • Provides specifications and creation of scripts to facilitate electronic safety reporting (setting up 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 clinical data management and EDC programming 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 of all stages of a clinical trial and vendor oversight
  • Experience of managing and mentoring EDC programmers
  • Demonstrated knowledge of ICH/GCP guidelines as they relate to clinical data management
  • Thorough understanding of CDISC CDASH and SDTM standards
  • Extensive experience managing Medidata and other EDC data vendors.
  • 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.
  • Excellent communication/interaction skills and experience in a dynamic and growing organization.
  • 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.
  • A minimum 10+ years’ related 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.
  • A minimum of 8 years previous EDC programming management experience is preferred.
  • Advanced knowledge of EDC systems and of data structures within these systems.
  • Must be able to demonstrate extensive experience in programming EDC databases, CRF design, query resolution, and general data validation, preferably using Medidata Rave, as an EDC programmer within Clinical Data Management or SAS programmer.
  • Experience with a Metadata Repository or other related standards management system is a plus.
  • Experience with eClinical Solutions is preferred.
  • 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 the management of 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).
  • 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 to study teams and within Clinical Data Management are required.

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and
  • temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel

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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Associate Director, Electronic Data Capture Programming, Other , Palo Alto, California

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