Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Data Manager.
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, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The GDM will be responsible to 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 the GDM establishes conventions and quality expectations for clinical data and sets timelines and follow-up regularly to ensure delivery of all Data Management milestones.
The Sr. GDM will ensure compliance with Standard Operating Procedures (SOPs), policies and regulatory requirements from trial start-up through data-base lock and trial close-out. Represent functional area(s) in divisional/company-wide process initiatives.
Principal responsibilities will include:
? Performs trial level oversight controls as described in the oversight plan, Quality Control (QC)
process and work instructions with minimal Data Delivery Lead (DDL) direction.
? Reviews clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
? Ensures real-time inspection readiness of all Data Delivery (DD) deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
? Plans and tracks 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 DD and TA trial needs and deliverables are met.
? Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
? Identifies and participates in process, system, and tool improvement initiatives within DD.
? Presents and trains at investigator and monitor meetings.
+ A minimum of a BS/BA degree or professional experience equivalent.
+ Minimum of 3 years Clinical Data Management experience.
+ Experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
+ Electronic Data Capture (Medidata RAVE, Inform) platforms preferred
+ Experience in clinical drug development within the pharmaceutical industry or related industry.
+ SAS experience is desired
+ Vendor oversight experience is desired.
+ Team leadership experience is desired.
+ Project management experience is desired.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Primary Location
United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID

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