Janssen Research & Development, LLC, a
member the Janssen Pharmaceutical Companies of Johnson & Johnson is
recruiting for a Manager, Data Management Leader to be located at Janssen
campuses in Titusville NJ, Raritan, NJ, Spring House PA, Malvern, PA and/or Beerse, Belgium
Janssen Research & Development, L.L.C.
develops treatments that improve the health and lifestyles of people worldwide.
Research and development areas encompass novel targets in neurologic disorders,
gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic
disorders, immunologic disorders, and reproductive medicine.
The Data Management Leader
(DML) is responsible for managing data management deliverables for one or more
compounds in the Oncology Therapeutic area. This position serves as the single
point of contact and Clinical Team member for the R&D Company for data
- This position
makes decisions with direction from the Data Management Therapeutic Area
Head around timelines and budgets if decisions do not adversely impact the
functions or the quality of the deliverables.
- Together with
the functional Leader, this person will make decisions around resource
allocation within the project to ensure priorities are being addressed.
Decisions that impact the resource allocations across projects should be
discussed with functional management.
- S(He) will
provide input around choice of ESP for data management activities. .
- This position
analyzes and provides rationale to recommend decisions with direction from
the Data Management Therapeutic Area Head. The DML Manager keeps
functional leaders and data management specific area leaders informed of
- The DML
develops and offers solutions to issues that arise on the project and
implements the solutions. Other resources are at the DMLs disposal for
information or for second opinions. This position provides input to
performance reviews for team members and participates in the interview
process for new hires.
- This position
requires a working knowledge of data management tools and processes. An
in-depth knowledge of project management tools and processes is needed.
- This is a
project management position focusing on data management reporting directly
to the Data Management TA Head Oncology. Assignments are received from the
Data Management TA Head.
- Status of work
is regularly reviewed by the Data Management TA Head. The amount of
instruction received by this position is minimal. Issues possibly
impacting program timelines and quality are discussed with the Data
Management TA Head for approval.
- There are no
direct reports, but there is matrix reporting through the Global Data
Management Team. This position provides performance management feedback to
the functional managers for the GDMs that are working on the programs.
- This person will
serve as the data management point person to the clinical team of the
respective R&D Company for each assigned compound; keeps the team
updated on the progress of data management milestones; negotiates for
priority status and makes timeline adjustments as appropriate. Manages the
data management timelines and budgets; ensures milestones are delivered
with quality, on time, and within budget.
budget input for R&D Company business planning exercises. Partners
with functional management to ensure proper resource allocation and
training; negotiates for priority activities with the clinical team and
- Leads the data
management working group for each compound as needed. Coordinates
issues resolution activities and implements solutions. Participates in
process improvement initiatives.
- Works with
internal and external partners on indications of low to medium complexity.
Collaborates with internal cross-functional colleagues and external
partners on the integration of a restricted number of data streams for a
- Works with
Functional Leader to ensure real time inspection readiness for all IDS
deliverables related to relevant compounds. Works with Functional Leader
on regulatory agency inspections and J&J internal audits as necessary.
- A minimum of a bachelor's
degree is required, master's degree is preferred.
- A minimum of 8 years of
knowledge in the data management space is required.
- Project management experience
- Pharmaceutical or health care
experience, working with customers, experience working in teams,
experience with outsourcing and contract oversight, experience
managing Data Management budgets at a trial or compound level is
- Life sciences and Oncology
experience is preferred. Excellent written and verbal English
communications skills are required.
- Experience managing vendors is
- The Ability to effectively lead
a cross-functional team and interface with partners is required. This
position could be either located at Janssen campuses located on US
East Coast Titusville NJ, Raritan, NJ, Spring House, PA and/or Malvern, PA
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Johnson & Johnson is an equal opportunity
United States-New Jersey-RaritanOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Data ManagementRequisition ID
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