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Global Data Manager Specialist (1 of 2).

Company: Johnson & Johnson
Location: Titusville
Posted on: January 16, 2022

Job Description:

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for Global Data Manager (GDM) Specialist to be located in Spring House, PA; Raritan, NJ; or Titusville, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Principal Responsibilities
Takes a leadership role with the CRO, the trial customer(s), GDM and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Identifies and communicates ways to improve deliverables.
With the trial customer, CRO, GDM, and other functional partners: - Takes a leadership role to gather content and integration requirements for eCRF and other data collection tools. - Leads conventions and quality expectations for clinical data. - Leads expectations for dataset content and structure. - Sets timeline and follow-up regularly to ensure delivery of all data management milestones.
Ensures trial level oversight controls are performed as described in the oversight plan, QC process, and work instructions.
Ensures that clinical data management documents are reviewed accurately (including submission package) to facilitate 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 DM deliverables for the trial. Participates 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 DM and TA trial needs and deliverables are met. Collaborates with the DML to develop scope of work and identify needed resources. Works with Infrastructure Organization to ensure all deliverables are effectively completed.
Takes a leadership role to obtain and share best practices with internal partners. Leads others in implementing process, system, and tool improvement initiatives within DM.
Presents information and trains investigator and site monitors.
May undertake the principal responsibilities of a CDM, as appropriate.

Required Experience

Qualifications
A minimum of a BA/BS degree.
5 years of Data Management experience.
Experience in clinical drug development within the pharmaceutical industry or related industry.
Vendor oversight experience.
Team leadership experience.
Project management experience.

Preferred Experience
2 years of experience in therapeutic area.
3 years of experience as a Senior Global Data Manager.

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.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105974093W

Keywords: Johnson & Johnson, Trenton , Global Data Manager Specialist (1 of 2)., Executive , Titusville, New Jersey

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