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Senior Global Data Manager
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Global Data Manager. This position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Chesterbrook, PA; Beerse, Belgium; Leiden, Netherlands; Breda, Netherlands; High Wycombe, United Kingdom; or Allschwil (Basel), Switzerland.
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 http://www.janssenrnd.com for more information.
The Senior Global Data Manager (GDM),within the Integrated Data Analytics and Reporting (IDAR) organization, will provide oversight and accountability for more than one low to moderate complexity trial or one high complexity trial. This individual may also be a member of more than one project of low to moderate complexity or member of one project of high complexity. Make recommendations and influence decisions for specific trials or assignments. Influence processes, timing, and structure for specific trials or assignments. This position will analyze, provide recommendations, and make
decisions with direction from manager or Data Management Leader (DML).
This position will collaborate with vendors/Contract Research Organizations (CROs) to achieve successful, cooperative partnerships. May delegate tasks and assignments to GDMs. The Senior GDM will recognize opportunities and contribute to solutions to strengthen the vendor/CRO relationship.
Take a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
With the trial customer, CRO, and other functional partners: gather content and integration requirements for electronic Case Report Form (eCRF) and other data collection tools; establish conventions and quality expectations for clinical data; establish expectations for dataset content and structure; set timelines and follow‐up regularly to ensure delivery of all Data Management milestones.
Perform trial level oversight controls as described in the oversight plan, Quality Control (QC) process and work instructions with minimal DML direction.
Review clinical data management documents (including submission package), ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
Ensure real‐time inspection readiness of all DM deliverables for the trial. Participate in Regulatory Agency and Johnson & Johnson internal audits as necessary.
Plan and track 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.
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.
Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
Identify and participate in process, system, and tool improvement initiatives within DM.
Present and train at investigator and monitor meetings.
A minimum of a High School diploma is required. Bachelor’s degree in a Scientific discipline is preferred.
Data management experience is required.
Experience in clinical drug development within the Pharmaceutical industry, Contract Research Organization or related industry is required.
Experience with Electronic Data Capture (i.e. Medidata Rave, Inform) platforms preferred.
Vendor oversight experience is preferred.
Team leadership experience is preferred.
Project management experience is preferred.
Therapeutic Area experience is preferred.
Must have excellent verbal and written communication skills.
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 of disability.
United States-New Jersey-Raritan- Other Locations
United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Netherlands-North Brabant-Breda, Netherlands-South Holland-Leiden, United States-New Jersey-Titusville, United States-Pennsylvania-Chesterbrook Organization
Janssen Research & Development, LLC (6084) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies