Global Data Manager Specialist - Immunology (1 of 2)
Company: Johnson & Johnson
Posted on: February 23, 2021
Janssen Research & Development, LLC, a member of Johnson &
Johnson's Family of Companies, is recruiting for a Global Data
Manager Specialist - Immunology. This position can be located in
Raritan, NJ; Titusville, NJ; or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what
matters most is helping people live full and healthy lives. We
focus on treating, curing and preventing some of the most
devastating and complex diseases of our time. And we pursue the
most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical
needs in oncology, immunology, neuroscience, infectious diseases
and vaccines, cardiovascular and metabolism, and pulmonary
hypertension. Please visit for more information.
The Global Data Manager (GDM) Specialist - Immunology, within the
Integrated Data Analytics and Reporting (IDAR) organization, will
provide oversight and accountability for multiple low, moderate,
and high complexity trials. This individual may also be a member of
multiple projects of low, moderate, high complexity or a leader of
projects of low to moderate complexity. Make recommendations and
decisions that have an impact on specific trials or assignments.
Make decisions for processes, timing, and structure for trials and
assignments. Make recommendations for processes, timing, structure,
and resources at a program level. This position will analyze,
provide recommendations, and make decisions with minimal direction
from manager or Data Management Leader (DML).
This position will collaborate with vendors/Contract Research
Organizations (CROs) and Senior GDM to achieve successful,
cooperative partnerships. Recognize opportunities and contribute to
solutions to strengthen the vendor/CRO relationship. The GDM
Specialist will mentor and coach GDMs and Senior GDMs on trial
level responsibilities and may delegate work.
- Take a leadership role with the CRO, the trial customer(s),
Senior Global Data Manager and other internal and external partners
to establish, align and confirm data management expectations for
assigned trial(s). Identify and communicate ways to improve
- With the trial customer, CRO, GDM, and other functional
partners: take a leadership role to gather content and integration
requirements for electronic Case Report Form (eCRF) and other data
collection tools; lead conventions and quality expectations for
clinical data; lead expectations for dataset content and structure;
set timeline and follow---up regularly to ensure delivery of all
data management milestones.
- Ensure trial level oversight controls are performed as
described in the oversight plan, Quality Control (QC) process, and
- Ensure that clinical data management documents are reviewed
accurately (including submission package) to facilitate appropriate
quality, scientific content, organization, clarity, accuracy,
format and consistency. Ensure compliance with regulatory
guidelines and the documentation matrix.
- Oversee the assessment of real---time inspection readiness of
all data management deliverables for the trial. Participate in
regulatory agency and J&J internal audits as necessary.
- Lead 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. Ensure
deliverables are on time.
- Take a leadership role with the assigned clinical working
group(s) to ensure that Data Management (DM) and Therapeutic Area
(TA) trial needs and deliverables are met. Collaborate with the DML
to develop scope of work and identify needed resources. Work with
Infrastructure Organization to ensure all deliverables are
- Take a leadership role to obtain and share best practices with
internal partners. Lead others in implementing process, system, and
tool improvement initiatives within DM.
- Present information and train investigators and site
- A minimum of a High School diploma is required. Bachelor's
degree in a Scientific discipline is preferred.
- A minimum of 2 years of data management experience is
- Experience in clinical drug development within the
Pharmaceutical industry, Contract Research Organization or related
industry is required.
- Experience in the Immunology Therapeutic Area is required.
- Experience with Electronic Data Capture (i.e. Medidata Rave,
Inform) platforms preferred.
- Vendor oversight experience is preferred.
- Team leadership experience is preferred.
- Experience leading a change in data management techniques
and/or processes preferred.
- Project management experience is preferred.
- Must have excellent verbal and written communication
- Must have the ability to adapt to a rapidly changing
organization and business environment.
- The ability to collaborate with all levels of management across
a matrix environment is required.
- This position will require up to 10% travel.
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
Keywords: Johnson & Johnson, Trenton , Global Data Manager Specialist - Immunology (1 of 2), Executive , Titusville, New Jersey
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