Clinical Data Management Specialist – Data Reporting

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Job Description

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.

We are currently hiring for a Clinical Data Management Specialist – Data Reporting. This position can be based in Raritan, NJ; Spring House, PA; or Beerse, Belgium.

Within our Integrated Data Analytics & Reporting (IDAR) Data Management-Clinical Data Standards (DM-CDS) organization we are currently looking for individuals with the aptitude and motivation to further nurture and contribute to the growth of our Data Reporting and Study Specific Reporting space, within our Technical Data Architect (TDA) group. This is an exciting opportunity to be part of an innovative technical data management team that is pivotal in defining our next generation data and visualization strategies.

Position Summary:
As a Specialist and project leader this position facilitates the creation of study-specific reports translating clinical study team needs into specifications for aggregating clinical data sources into custom data and report solutions to monitor safety, risk and compliance. Provide operational oversight and technical project management of programming activities across multiple trials for assigned portfolio ensuring effective partnership with key stakeholders.

This position will report within Technical Data Architect Data Reporting Team and will work in close partnership with our Capability Leads as well as with other key subject matter experts across functional teams. In conjunction contribute to the improvement of clinical data safety review and cleaning efficiency by providing innovative and forward-thinking reporting solutions, report library templates, macros and other solutions for use cross studies.

Principle Responsibilities:
  • Serve as a primary report delivery contact for key stakeholders including risk based central monitoring, data management, clinical study team members, clinical scientists and physicians, risk management and central monitoring.
  • Accountable for planning and execution of study specific reporting activities across portfolio within areas of responsibility. This will include sustaining productive partnership with Risk Management – Central Monitoring team to develop reporting solutions in support of Analytical Risk-Based Monitoring (ARBM).
  • Proactively engage in project team meetings, lead and organize meetings to develop detailed plans and as applicable.
  • Partner with functional experts to translate requirements for data and reporting solutions creating standardized, replicable outputs and visualizations for self and programming teams
  • Analyze data sources, design and execute data reports, visualizations through understanding and translation of business requirements.
  • Provide hands on SAS programming, data manipulation for all aspects of data quality and clinical safety review reports.
  • Develop and maintain working knowledge and expertise in programming languages utilized in data analytics and reporting (SAS, R, R Shiny, Spotfire, etc.) and apply continuous learning and strategic thinking as part of our next generation of data and data sciences strategy.
  • Connect with user community to identify areas of opportunity where technical solutions that may drive a competitive advantage.
  • Inspire new and creative ways to meet data review objectives through proactive identification of gaps, inefficiencies in current processes and projects recommending opportunities for improvement.
  • Contribute to the development of reporting prototypes for new solutions as applicable.
  • Conceptualize new strategies that contribute to the improvement of existing reporting solutions.
  • Support and training of end users for implementation of reports, including development and execution of training material and process documentation.
  • Provide direction and guidance to junior team members on all aspects of data reporting and analytics from business context and prioritization to technical coaching.
  • Maintain knowledge of current industry trends and technologies relative to data reporting and data review to leverage where appropriate to optimize functional capability/efficiency.
  • Connect across technical groups within J&J to leverage institutional knowledge and solutions.
  • Actively contribute to internal knowledge base through Wikis, Forums and other collaboration mechanisms.

Education & Qualifications:
  • A Bachelor’s degree in Computer or Life Sciences and minimum of 5 years’ pharmaceutical industry experience in data management, clinical or statistical programming. Cumulative experiences in other relative industries such as Data Sciences roles will also be considered.
  • Proficiency in SAS is required and R, Python experience a plus.
  • Knowledge of Analytical Risk-Based Monitoring concepts.
  • Experience in using tools intended for report writing, analytics, visualizations, or dashboard creation such as Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI or Crystal Reports a plus.
  • Proven proficiencies in project and resource management.
  • Able to communicate technical information in a non-technical fashion.
  • Able to work independently and in a team environment.
  • Competencies Strong analytic and problem-solving skills.
  • Ability to think holistically to help identify opportunities and shape data reporting solutions to better meet data review objectives. As well as a proven track record in partnering with others to gather and frame out strong requirements that can be quickly prototyped and leveraged into practical solutions for customers.
  • Forward-thinking problem-solving skills, attention to detail, good verbal and written communication and organizational skills are required.
  • Experience working on cross-functional teams is preferred with demonstrated effective communication skills and experience working within a matrix environment.
  • Intermediate to advanced Microsoft Excel experience including data analysis is a plus. Strong understanding of relational databases and industry standard data models are required.
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
North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)
Job Function
Requisition ID