Associate Director, Clinical Data Management
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, 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
- 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 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
- Contribute to strategic planning to ensure optimized use of
clinical data management resources within the area of
- 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 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
- Experience of managing and mentoring clinical data
- 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
- 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 is
- At least ten years’ experience in Clinical Data Management for
the pharmaceutical/biotechnology industry, or equivalent experience
in an FDA-regulated environment is required
- Several years of study lead and supervisory experience is
- Hematology/Oncology experience and working with collaborative
oncology groups is preferred
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, Clinical Data Management, Other , Palo Alto, California
Didn't find what you're looking for? Search again!