Senior Manager, Clinical Data Management
Company: Jazz Pharma
Location: Palo Alto
Posted on: April 10, 2021
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Job Description:
Overview: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 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.Responsibilities:The Sr. Manager, Clinical Data
Management (Sr. Manager, CDM) will oversee the data management of
clinical trials in a large or complex 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 studies through vendors. S/he may lead a
small team of junior and senior Clinical Data Managers and/or lead
a technical development area (e.g. process, innovation, training,
etc.). S/he will facilitate effective internal and external
relationships. S/he will be expected to contribute to the
development and growth of the CDM group within the Clinical
Development Operations (CDO) structure. S/he will fulfill the
following functions:Essential Functions* Oversee (and sometimes
lead) the data management of Phase 1 through Phase 4 clinical
trials in a large or complex development program* Provide
leadership, and mentoring to junior and senior Clinical Data
Managers assigned to his/her line management* Participate in and/or
lead the development and implementation within a technical
development area (e.g. process and standards, innovation, training,
etc.)* Represent Clinical Data Management on the Development Core
Team and/or Clinical Trial Working Groups as appropriate* Provide
input to the development and implementation of methods to
demonstrate oversight of CROs and other vendors, and manage and/or
monitor the progress of outsourced data management activities*
Provide input and direction in CRO and vendor selection and
management* Provide technical expertise for the development of data
management and other clinical trial documents (Clinical Data
Management Plans and associated documents, Protocols, Centralized
Monitoring Plans, Statistical Analysis 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 excellence* Contribute to
strategic planning to ensure optimized use of clinical data
management resources within the area of responsibility* Participate
in the generation and approval of budgets and timelinesRequired
Knowledge, Skills, and Abilities* Thorough knowledge of 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 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 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
RequiredRequired/Preferred Education and Licenses* Bachelor's
Degree required (Master's Degree preferred) in the
scientific/healthcare field* At least eight years of experience in
Clinical Data Management for the pharmaceutical/biotechnology
industry, or equivalent experience in an FDA-regulated environment,
including study lead experienceJazz 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 Pharma, Palo Alto , Senior Manager, Clinical Data Management, Executive , Palo Alto, California
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