Senior Clinical Data Manager
Company: Jazz Pharma
Location: Palo Alto
Posted on: February 25, 2021
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
The Clinical Data Manager will be responsible for performing Data
Management activities that support Jazz Pharmaceuticals' commercial
and development projects worldwide. He/she will participate as an
active member of a multi-disciplinary team to plan, lead and
execute the Data Management tasks required for phase 1-4 studies.
The Clinical Data Manager has a broad, fundamental knowledge of the
data management process and is able to perform most required tasks
with minimal guidance.
The Clinical Data Manager will:
* Be able to lead a large clinical study or a series of related
studies with minimal guidance
* Represents Data Management on the CTWG for assigned studies
* Provide mentoring and training to lower level Data Management
staff assigned to his/her studies
* Manage and monitor the progress of data management activities
with CROs or other vendors on assigned studies; build effective
relationships with CRO / vendor counterparts
* Review protocols for appropriate data capture including
electronic Case Report Form (eCRF) design.
* Be able to perform a thoroughly detailed review of eCRF data
* Interact with CRAs, programmers, study managers and statisticians
in designing eCRFs and creating the annotated eCRF and CRF
* Lead the development of data edit check specifications and data
* Coordinate the design and testing of Electronic Data Capture
(EDC) systems according to company standards. Able to resolve EDC
system issues with team members
* Develop or lead the development of the Data Management Plan for a
* Able to review and provide feedback to the clinical team on other
study documents e.g. Clinical Monitoring plans, Statistical
analysis plans and vendor specifications
* May provide training on the EDC system and/or eCRF Completion
Guidelines at Investigator Meetings and to internal and external
study team members as needed
* Perform reconciliation of header data from external data sources
against the clinical database
* Perform Serious Adverse Event reconciliation activities according
to SOPs and guidelines
* Lead database upgrades/migrations including performing User
* Be able to maintain study workbooks and data management files
* Perform database lock and freeze activities per company SOPs
* Participate in regular team meetings and provide input when
* Provide input into the development of data management SOPs, Work
Instructions, and process documents; take a leadership role in the
development of assigned documents
* Contribute to a professional working environment including the
application of Jazz Pharmaceuticals Code of Business Conduct and
* Assist with the training of new employees and/or contractors
Bachelor's Degree required (Master's Degree preferred) in the
At least five years' experience in Data Management for the
pharmaceutical/biotechnology industry, or equivalent experience in
an FDA-regulated environment, including study lead experience
Has good project management skills and a proven ability to
Understands the scope and focus of Phase 1-4 clinical studies, and
has a proven ability to perform most of the core Data Management
tasks and interact with vendors.
Possesses a comprehensive understanding of regulatory guidelines
and industry standards (e.g., ICH/FDA guidances, CDISC standards,
GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their
application to Data Management practice.
Attention to detail and the ability to work individually, within a
multi-disciplinary team, as well as with external partners and
Possesses strong English language written and verbal communication
Experience and understanding of the Oncology or CNS therapeutic
area, and with Phase III pivotal studies are preferred.
Able to travel to off-site meetings or training seminars as
Possesses solid computer system and technical skills with a strong
ability to learn multiple computer applications.
Prior experience with different Data Management systems and
technologies, and Electronic Data Capture systems is desirable.
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 Data Manager, Healthcare , Palo Alto, California
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