Global Data Manager Specialist (1 of 2).
Company: Johnson & Johnson
Posted on: January 16, 2022
Janssen Research & Development, L.L.C., a division of Johnson &
Johnson's Family of Companies is recruiting for Global Data Manager
(GDM) Specialist to be located in Spring House, PA; Raritan, NJ; or
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives
by finding new and better ways to prevent, intercept, treat and
cure disease inspires us. We bring together the best minds and
pursue the most promising science.
We are Janssen. We collaborate with the world for the health of
everyone in it. Learn more at www.janssen.com and follow us
@JanssenGlobal. Janssen Research & Development, LLC is part of the
Janssen Pharmaceutical Companies.
Takes a leadership role with the CRO, the trial customer(s), GDM
and other internal and external partners to establish, align and
confirm data management expectations for assigned trial(s).
Identifies and communicates ways to improve deliverables.
With the trial customer, CRO, GDM, and other functional partners: -
Takes a leadership role to gather content and integration
requirements for eCRF and other data collection tools. - Leads
conventions and quality expectations for clinical data. - Leads
expectations for dataset content and structure. - Sets timeline and
follow-up regularly to ensure delivery of all data management
Ensures trial level oversight controls are performed as described
in the oversight plan, QC process, and work instructions.
Ensures that clinical data management documents are reviewed
accurately (including submission package) to facilitate appropriate
quality, scientific content, organization, clarity, accuracy,
format and consistency. Ensures compliance with regulatory
guidelines and the documentation matrix.
Oversees the assessment of real-time inspection readiness of all DM
deliverables for the trial. Participates in regulatory agency and
J&J internal audits as necessary.
Leads the planning and tracking of content, format, quality, and
timing of data management deliverables, including, but not limited
to, CRF, data review plan, QC plan, oversight plan, database
release plan, final datasets, submission plan and archival. Ensures
deliverables are on time.
Takes a leadership role with the assigned clinical working group(s)
to ensure that DM and TA trial needs and deliverables are met.
Collaborates with the DML to develop scope of work and identify
needed resources. Works with Infrastructure Organization to ensure
all deliverables are effectively completed.
Takes a leadership role to obtain and share best practices with
internal partners. Leads others in implementing process, system,
and tool improvement initiatives within DM.
Presents information and trains investigator and site monitors.
May undertake the principal responsibilities of a CDM, as
A minimum of a BA/BS degree.
5 years of Data Management experience.
Experience in clinical drug development within the pharmaceutical
industry or related industry.
Vendor oversight experience.
Team leadership experience.
Project management experience.
2 years of experience in therapeutic area.
3 years of experience as a Senior Global Data Manager.
Johnson & Johnson is an Affirmative Action and Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, age, national origin, or protected
veteran status and will not be discriminated against on the basis
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States-New Jersey-Raritan, North
America-United States-New Jersey-Titusville
Janssen Research & Development, LLC (6084)
Keywords: Johnson & Johnson, Trenton , Global Data Manager Specialist (1 of 2)., Executive , Titusville, New Jersey
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