Associate Director, Clinical Data Management
Palo Alto, California
Expiry Date :
Sat, 12 Jun 2021 23:59:59 GMT
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Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases – often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our team. If youre 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 youll explore our career openings and get to know Jazz Pharmaceuticals.
The Associate Director, Clinical 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 clinical 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 Clinical Data Management group within the Clinical Operations
* Oversee (and sometimes lead) the data management of Phase 1 through 4 clinical trials in a particular therapeutic area or development program
* Develop and implement methods to demonstrate oversight of CROs and other vendors
* Provide direction and leadership in CRO and vendor selection and management.
* 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 Clinical 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 excellence.
* Contribute to strategic planning to ensure optimized use of clinical 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 timelines
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
* Thorough knowledge of clinical 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 interactions with clinical data management
* Experience of all stages of a clinical trial and vendor oversight
* Experience of managing and mentoring clinical data managers
* Demonstrated knowledge of ICH/GCP guidelines as they relate to clinical data management
* 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 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 Required
REQUIRED/PREFERRED EDUCATION AND LICENSES
* BA/BS, preferably in the scientific/healthcare field.
* At least ten years experience in Clinical Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
* Several years of study lead and supervisory experience
* For Hematology/Oncology, experience working with collaborative oncology groups
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._