Head of Data Management, Central Services

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Head of Data Management for Central Services. This position can be based out of Raritan, NJ; Titusville, NJ; Spring House, PA; or Beerse, BE.

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.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Head of Data Management, Central Services within the Integrated Data Analytics and Reporting (IDAR) group is responsible for providing input to Data Management strategy and deliverables for a therapeutic area, aligned to the overall IDAR and GCDO/RDO strategies. This position is also responsible to collaborate with the peers, DM Head, TA Standards Leads, EBIS and IT to provide input on process optimization and innovation within the therapeutic area assigned, ensuring alignment across IDAR.

This position supervises Clinical Data Acquisition Experts and Clinical coding, supporting all TAs, and is accountable to own one or more Technical DM processes impacting all TAs. This position is also accountable for recruiting, resource planning, management and development of all employees within their organization to meet current and future business needs. Coaching and mentoring others as needed.

Responsibilities:

Provides input to Data Management strategy and deliverables, process optimization and innovation across compounds and projects across Therapeutic Areas.

  • As part of the Data Management leadership team, contributes to decisions on business strategy, technical DM processes, sourcing and resource allocations across sites. Provides strategic input into the evaluation and reassessment of departmental processes.
  • Identifies process optimization and innovation across therapeutic areas within technical data management, such as technical eCRF build, trial level Data Transfer Agreement optimization, real time access to data, business system support and ensures alignment of processes and procedures.
  • Provides input to DM TA heads on study prioritization and resource allocation to ensure programs within therapeutic area assigned are supported. Provides input and approval on resource demand for therapeutic area as part of budget planning in conjunction Data Management peers and Head.
  • Makes recommendations around process/policy deviations to adhere or adjust to local or project requirements.

Provides leadership to the Data Management team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
  • Charged with making decisions associated with the management of assigned personnel and local administration, including hiring, performance management, space allocation, supplies, budget, travel, etc.
  • Undertakes people development responsibilities through coaching, training, and performance management as well as ensure compliance with department SOP's, policies and regulatory guidance documents.
  • Accountable for the decisions made by the Clinical Data Acquisition Experts and Clinical Coding experts from a performance perspective.
  • Coordinates with other DM Therapeutics Heads and other colleagues to ensure alignment of departmental roles and responsibilities.

Accountable to provide input into the development of departmental policies, procedures, training and standards.
  • Policy and standards development and compliance as it relates to the therapeutic area assigned.
  • Participates in and/or lead global cross-functional and cross-company initiatives, as applicable.
  • Own one or more department procedures, ensuring the processes are up to date and efficient.
  • Lead process improvement projects, as needed, to continue building best in class Data Management organization.

This position reports to Data Management Head (DM). There are regular interactions with the DM Head, IDAR Head and senior leadership to identify and share input for strategies and approaches. Work is received in broad terms and this position is provided independence for execution.

This position supervises Clinical Data Acquisition Experts.

Additional Responsibilities:
  • Participates in IDAR and GCDO initiatives as assigned.
  • Regularly meets with direct reports to ensure consistency and appropriate progress towards project goals.
  • Collaborates and partners with cross-functional leadership to drive issue escalation and issue resolution, and champion best practices.
  • Collaborates with vendor to optimize sourcing decisions

Qualifications

  • A minimum of a Bachelor's of Science (or University equivalent)plus 10 years of experience in a leadership function in clinical data management or technical clinical data management is required (MS is preferred)
  • Excellent people leadership skills and people management experience of 5 years is strongly preferred
  • Extensive understanding of data science / data management and general knowledge of clinical operations and statistical programming practices and systems is required
  • The Head of Data Management for Central Services requires a knowledge of regulatory guidance documents such as ICH requirements, inter-departmental processes, and relevant Clinical R&D concepts
  • In-depth knowledge of project management, team leadership and people development practices is preferred
  • This position requires knowledge related to talent development and relevant personnel policies and procedures
  • This position also requires knowledge of cross-functional working environment and industry trends that influence departmental resources
  • Knowledge of sourcing strategies, resource management, and organizational impact is required
  • Excellent leadership, decision-making skills and proven ability to foster team productivity and cohesiveness is required
  • The ability to operate and execute without supervision is required


Primary Location
United States-New Jersey-Raritan
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
00001C6E


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