Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Global Data Manager. The position based in Belgium, Netherlands, UK, Canada, US & Switzerland but there is potential for remote opportunities Remote work options may be considered on a case-by-case basis and if approved by the Company.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

POSITION SUMMARY:

• Type of Role: This is a professional individual contributor role that provides oversight and accountability for multiple low, moderate, and high complexity trials. May be a leader of multiple projects of low, moderate, high complexity. This position takes a leadership role in support of the DML on program level oversight responsibilities. This position will serve as a resource for a specific area of expertise.
• Impact of Decision-Making: This position makes recommendations and decisions that have an impact on a program level. The Principal GDM makes decisions for processes, timing, and structure for trials and assignments. This position makes decisions for processes, timing, structure, and resources at a program level.
• Accountability/Decision-Making: This position analyzes, provides recommendations, and makes decisions in collaboration with the DML, DMTA Head, Data Operations Head, or Data Management Infrastructure Group.
• Knowledge: This position requires expert knowledge of the protocol, current clinical drug development processes. Knowledge of applicable international guidelines regarding clinical trials end to end. Relevant system / technical knowledge are needed. Expert knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.), the therapeutic area, project management techniques, and team management principles is required.
• Supervision Received: Work is received in broad terms. Work is reviewed during major deliverables. This position is provided with independence for execution. Work is completed in collaboration with the Data Manager Leaders, the DMTA Head, Data Management Operations Head, or with Data Management Infrastructure Organization.
• Supervision Given: There are no direct reports for this position. This position collaborates with Vendors/CROs and Senior GDMs to achieve successful, cooperative partnerships at the program level. This position recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship. The Principal GDM mentors and coaches GDMs, Senior GDMs, and Specialists on compound level responsibilities and may delegate work to GDMs, Senior GDMs, and Specialists.
• GDO Common Competencies: Primarily at the Applying Level, see Appendix for competencies and proficiency levels.
• DM Specific Competencies: Primarily at the Applying or Leading Level, see Appendix for competencies and proficiency levels.

PRINCIPAL RESPONSIBILITIES:

• Takes a leadership role with the CRO, the trial customer(s), GDM, DML, and other internal and external partners to establish, align and confirm data management expectations for assigned program sub tasks. Identifies and communicates ways to improve expectations.
• With the trial customer, CRO, GDM, DML and other functional partners:
• Oversees the gathering of content and integration requirements for eCRF and other data collection tools over trials within a program.
• Leads conventions and quality expectations for clinical data.
• Leads the setting of expectations for dataset content and structure over trials within a program.
• Ensures timelines are established and that follow-up occurs regularly to ensure delivery of all data management milestones.
• Ensures trial level oversight controls are performed in a consistent way within a program.
• Ensures that clinical data management documents are reviewed accurately (including submission package) to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format and consistency at the program level. Ensures compliance with regulatory guidelines and the documentation matrix at the program level.
• Oversees the assessment of real-time inspection readiness of all DM deliverables for the trials within a program. Co-leads regulatory agency and J&J internal audits as necessary.
• Oversees and guides 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 at the program level. Oversees the monitoring and tracking of deliverables.
• Collaborates with the DML and the DMTA Head to distribute work assignments and identify needed resources.
• Collaborates with Infrastructure Organization to ensure all deliverables are effectively completed.
• Takes a leadership role to obtain, share, and develop best practices with internal and external partners. Leads others in developing and implementing process, system, and tool improvement initiatives within DM.
• Acts as backup for DML in the clinical team.
• May undertake the principal responsibilities of a DML, as appropriate.

Qualifications:

• BA/BS required or equivalent
• 4- 6 years of Data management experience required
• Experience in clinical drug development within the pharmaceutical industry or related industry required
• Vendor oversight experience required
• Team leadership experience required
• Project management experience required

Desired Experience:

• 4-5 years of experience in therapeutic area preferred
• 2-3 years of experience as a Senior Global Data Manager preferred

SPECIALIST POTENTIAL ACCELERATOR OPPORTUNITIES:

• Partner with functional manager in the development and coaching of GDMs.
• Volunteer to take full responsibility for the management of a complete program.
• Drive a team successfully though the development and implementation of a business change or innovative way of working.
• Take a leadership role in domain expertise across the global J&J organization and within the industry.
• Enhance and expand networks that include peers and senior management across the J&J organization.
• Take a leadership role in an industry organization, panel, or user group.
• Deliver a presentation to the leadership team with confidence; lead a team or leadership meeting and facilitate group discussions to ensure understanding and achieve the best possible outcome. It is important that you are effective in achieving your current goals and objectives, prior to engaging in accelerator experiences

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

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.

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PRIMARY LOCATION

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

OTHER LOCATIONS

Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Switzerland, North America-Canada, Europe/Middle East/Africa-Netherlands

ORGANIZATION

Janssen Research & Development, LLC (6084)

JOB FUNCTION

R&D

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