Janssen Research & Development, L.L.C., a member of Johnson & Johnson Family of Companies, is recruiting for a Senior Global Data Manager in Springhouse, PA, remote within the United States or Europe.
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, metabolic, and retinal diseases. Please visit http://www.JanssenRnD.com for more information.
Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.Principal Responsibilities:
- Works with CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations to the business for assigned trial(s).
- With the trial customer, CRO and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Participates in establishing conventions and quality expectations for clinical data. – Participates in establishing expectations for dataset content and structure. – Works with others to set timelines and follows-up regularly to monitor delivery of all data management milestones.
- Performs trial level oversight controls as described in the oversight plan, QC process, and work instructions, with DML direction.
- Reviews clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Works with DML to facilitate compliance with regulatory guidelines and the documentation matrix.
- Works with DML to facilitate real-time inspection readiness of all DM deliverables for the trial. Participates in regulatory agency inspections and J&J internal audits as necessary.
- Works with DML to 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. Works with DML to ensure deliverables are on time.
- Supports the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met.
- Identifies and communicates lessons learned with support from DML and frequently asked questions at trial level.
- Participates in process, system, and tool improvement initiatives within DM.
- Presents at investigator and monitor meetings.
- May undertake the principal responsibilities of a CDM, as appropriate
Education and Experience Requirements:Core Experience:
- BS/BA degree or professional experience equivalent required
- A minimum of 4 years of work experience is required
- Data management experience required
- Experience in clinical drug development within the pharmaceutical industry or related industry required
- Vendor oversight experience preferred
- Team leadership experience preferred
- Project management experience preferred
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.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com
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United States-Pennsylvania-Spring House-Welsh & McKean Roads
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, Asia Pacific-China, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Belgium, North America-United States
Janssen Research & Development, LLC (6084)