Senior Clinical Trials Manager
Company: Jazz Pharma
Location: Palo Alto
Posted on: January 8, 2021
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Job Description:
OVERVIEW: 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 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. RESPONSIBILITIES:
The Senior Clinical Trials Manager (Sr. CTM) will be a member of
the Jazz Pharmaceuticals Development Operations team. The Clinical
Trials Manager responsibilities include (but are not limited to)
the following: ESSENTIAL FUNCTIONS * Manage external vendors and
contract research organizations * Prepare study documents such as
the Monitoring Manual, Study Operations Manual, Source Data
Verification Plan and Laboratory Manual * Coordinate and be
responsible for the design of study materials such as CRFs, patient
diaries, study participation cards and source documents * Assist
with protocol development and study report completion * Manage
monitoring activities (may include routine on-site clinical
monitoring) at clinical study sites to assure adherence to Good
Clinical Practices (GCPs), SOPs and study protocols * Provide
guidance, direction, and management to CRAs * Track patient
enrollment; qualify, initiate, monitor, perform closeout
activities, and review site reports; and assist in coordination of
data management activities * Coordinate study supplies * Negotiate
contracts with vendors of clinical trial services * Review Informed
Consent Forms, CRFs, and study related materials Plan and
participate in investigator meetings * Assist and support data
query process * Assure regulatory compliance of investigational
sites with Jazz Pharmaceuticals SOPs and FDA and ICH guidelines *
Ensures trial master file is current and maintained REQUIRED
KNOWLEDGE, SKILLS, AND ABILITIES * At least 5 years of experience
in clinical trial management Experience in CNS is preferred *
Proven Management of people in a matrixed environment Management of
global clinical trials * Demonstrated working knowledge of GCP, ICH
guidelines and FDA regulations Demonstrated ability to work
independently and in a team environment * Travel required. Must be
willing to travel 15-25%, including international travel
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
* Excellent oral and written communication skills and strong
organizational abilities REQUIRED/PREFERRED EDUCATION AND LICENSES
BA/BS, nursing degree, or advanced degree. Degree in the life
sciences 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
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._
Keywords: Jazz Pharma, Palo Alto , Senior Clinical Trials Manager, Healthcare , Palo Alto, California
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