Global Data Manager Specialist

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

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.

Position Summary:

This is a professional individual contributor role that provides oversight and accountability for multiple low, moderate, and high complexity trials. May be assigned as team member of multiple projects of low, moderate, high complexity or a leader of projects of low to moderate complexity. This position makes recommendations and decisions that have an impact on specific trials or assignments. The GDM Specialist makes decisions for processes, timing, and structure for trials and assignments. This position analyzes, provides recommendations, and makes decisions with minimal direction from manager or DML.

This position collaborates with Vendor/CRO and GDM to achieve successful, cooperative partnerships. This position recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship.

The GDM Specialist mentors and coaches GDMs and Senior GDMs on trial level responsibilities. May delegate work to GDMs and Senior GDMs.

Principal Responsibilities:

• Develops 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.

• 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 timelines and follows‐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.

Education and Experience Requirements:

BA/BS degree or professional experience equivalent within a Pharmaceutical, CRO, and or Bio-Tech environment is required

5+ years of prior Data management experience required

Experience in clinical drug development within the pharmaceutical industry or related industry required

Vendor oversight experience preferred

The position requires knowledge of applicable international guidelines regarding clinical trials end to end.

This position requires expert knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) and the therapeutic area.

In‐depth knowledge of project management and techniques and knowledge of team management principles.

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-New Jersey-Raritan-Other Locations

United States-Pennsylvania-Chesterbrook, United States-New Jersey-Titusville, United States-Pennsylvania-Spring HouseOrganization

Janssen Research & Development, LLC (6084)Job Function

R&DRequisition ID

2907200331