Jazz Pharmaceuticals is an international biopharmaceutical
company focused on improving patients' lives by identifying,
developing and commercializing meaningful products that address
unmet medical needs. We are continuing to expand our commercial
product portfolio and our research and development pipeline in
therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.
We are looking for the best and brightest talent to join our
team. If you're looking to be a part of a company with an
unwavering commitment to improving patients' lives and being a
great place to work, we hope you'll explore our career openings and
get to know Jazz Pharmaceuticals.
The Associate Director, Data Management will oversee the data
management of clinical trials in a particular therapeutic area or
development program. S/he may also lead critical studies in this
area of responsibility. S/he will provide oversight to the daily
operations of Jazz Pharmaceuticals' clinical programs through
vendors. S/he may lead a team of data management professionals and
will be expected to provide vision, leadership, and mentoring to
their assigned team. S/he will facilitate effective internal and
external relationships. S/he will be expected to contribute
extensively to the development and growth of the Data Management
group within the Clinical Operations structure
* Oversee (and sometimes lead) the data management of Phase 1
through 4 clinical trials in a particular therapeutic area or
* Develop and implement methods to demonstrate oversight of CROs
and other vendors
* Provide direction and leadership in CRO and vendor selection
* Provide technical expertise for the development of data
management and other clinical trial documents (Data Management
Plans and associated documents, Protocols, Centralized Monitoring
Plans, etc.) and trial conduct
* Be responsible for and manage data management activity of
Clinical Data Managers assigned to his/her trials
* Ensure that the Data Management component of the TMF and other
documentation required to support regulatory submissions and
inspections are maintained to the standard required
* Coordinate closely with Clinical Operations, Clinical
Development, Biostatistics, Statistical Programming, Drug Safety,
Project Management and Regulatory to ensure operational
* Contribute to strategic planning to ensure optimized use of
data management resources within the area of responsibility
* Provide vision, leadership, and mentoring to staff assigned to
his/her line management
* Participate in and/or lead the development and implementation
of standards and processes related to both clinical data and
risk-based trial management
* Participate in the generation and approval of budgets and
Required Knowledge, Skills, and Abilities
* Thorough knowledge of data management and its role in the drug
* Understanding of the contributions of other functions critical
to the execution of clinical trials, and their interactions with
* Experience of all stages of a clinical trial and vendor
* Experience of managing and mentoring clinical data
* Demonstrated knowledge of ICH/GCP guidelines as they relate to
* Thorough understanding of CDISC CDASH and SDTM standards
* Extensive experience managing CROs and other data vendors.
* 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 Required
Required/Preferred Education and Licenses
* BA/BS required, preferably in the scientific/healthcare
* At least ten years' experience in Data Management for the
pharmaceutical/biotechnology industry, or equivalent experience in
an FDA-regulated environment
* Several years of study lead and supervisory experience
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
* 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.