Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Senior Global Data Manager, located in Titusville NJ, Raritan, NJ or Spring House, PA.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
- The Senior Global Data Manager takes 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 Senior Global Data Manager.
- Gathers content and integration requirements for eCRF and other data collection tools.
- Establishes conventions and quality expectations for clinical data. Establishes expectations for dataset content and structure.
- Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
- Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
- Reviews clinical data management documents (including submission package) 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 IDS 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 IDS 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 IDS. Presents and trains at investigator and monitor meetings.
- Bachelor's degree is required. Clinical Data Management experience is required.
- Experience in clinical drug development within the pharmaceutical industry or related industry is required.
- Electronic Data Capture (Medidata Rave, Inform) platforms preferred.
- In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) preferred.
- Vendor oversight experience preferred.
- Team leadership experience preferred.
- Project management experience preferred.
- SAS experience preferred.
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-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-Titusville, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Data Management
A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.