Associate Director, Electronic Data Capture Programming
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: July 17, 2021
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
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
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
- 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
- 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
- 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
- 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
- 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
- Partakes in the development and/or advancement of other data
capture technologies, in line with Jazz’s standardization goals and
- 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
- Assists in formalizing and assessing quality of the standards
- 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
- 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
- Experience working with a globally distributed team
- Ability to work on and solve complex problems.
- Ability to prioritize and handle multiple tasks
- 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
- 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
- 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
- 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
- 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
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
- Occasional public contact requiring appropriate business
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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