Manager, Data Management Leader
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
000016U4/3-en-us

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 management.   

 
  • 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 decisions.
  • 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.
  • Provides 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 the functions.
  • 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 program.
  • 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.
 
 


Qualifications
  • 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 is required. 
  • 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 required. 
  • Life sciences and Oncology experience is preferred. Excellent written and verbal English communications skills are required. 
  • Experience managing vendors is required. 
  • 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 is required.
 

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

 

Johnson & Johnson is an equal opportunity employer 

 


Primary Location
United States-New Jersey-Raritan
Other 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-Beerse
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
000016U4

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