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Principal Global Data Management Specialist
Requisition ID: 5720170712
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 Specialist 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 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:
Ensures trial level oversight controls are performed as described in the oversight plan, Quality
Control (QC) process and work instructions with minimal Data Delivery Lead (DDL) direction.
Ensures that clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
Oversees the assessment of real-time inspection readiness of all Data Delivery (DD) deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
Leads 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. 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.
Takes a leadership role to obtain and share best practices with internal partners.
Presents and trains at investigator and monitor meetings.
- A minimum of a BS/BA degree, Master degree preferred.
- Minimum of 7 years of Clinical Data Management experience.
- Electronic Data Capture (Medidata RAVE, Inform) platforms preferred
- Experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Experience in clinical drug development within the pharmaceutical industry or related industry.
- SAS experience desired.
- Vendor oversight experience required.
- Team leadership experience required.
- Project management experience required.
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.
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Data Management