Johnson & Johnson Careers

Data Processing Solutions Lead

Spring House, Pennsylvania; Raritan, New Jersey; Titusville, New Jersey; Beerse, Belgium
Clinical Data Management


Job Description

Requisition ID: 0635180827

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Data Processing Solutions Lead.  The preferred location for this position is Spring House, PA.  Alternate locations are Raritan, NJ; Titusville, NJ or Beerse, Belgium.
 
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.
 
The Data Processing Solutions Lead will provide expertise in clinical data processing technologies for the internal Clinical Data Management and Analytics and Quantitative Sciences (QS) organizations.  As a member of the Data Processing Solutions (DPS) team, this individual will develop knowledge and experience in clinical data management and programming technologies and take responsibility for projects to create new and improve solutions for the clinical trial teams.
 
The Data Processing Solutions Lead will impact processes, project timelines, priorities and functionality of conducting clinical trials and clinical trial software.  This individual will analyze and provide rationale to recommend decisions, keeps specific area leaders informed of decisions.  Interact with Data Delivery and Data analysis clinical teams, biostatisticians, medical writing and Electronic Data Capture (EDC) vendors.  This position has no direct reports, however will provide direction to external vendors and contractors.
 
Responsibilities will include:
  • Provide guidance and expertise to the Integrated Data Analytics and Reporting (IDAR) teams using data processing solutions.
  • Oversee the following solutions part of the portfolio: SAS drug development platform (SAAS based solution tailored to the life sciences industry); SAS programming and support processes; customized web platform to automate clinical data management activities (i.e. clinical standards library management, clinical study specification setup, clinical data validation); conversion tooling to translate electronically captured data into datasets for regulatory submissions and for analysis.
  • Share the expertise to support the clinical data delivery and analysis teams and Contract Research Organizations (CROs), by organizing trainings and organizing direct support when needed.
  • Deliver on medium complexity projects.
  • Participate in and lead projects in collaboration with IT to deliver new solutions to the user base.
  • Determine new solutions based on strategic direction or emerging needs within the business.
  • Participate in creation of user requirement specifications.
  • Participate in the deployment of new solutions, conduct and lead User Acceptance Testing (UAT) in collaboration with the targeted user community.
  • Develop guidance materials and training for integrating the new tools into the business processes.
  • Identify, participate or lead in process, system, and tool improvement initiatives.
  • Contribute to a continuous improvement and innovation culture with respect to the current and future data processing solutions.
  • Deliver and continuously improve a harmonized approach to system validation and support across Global Clinical Development Operations (GCDO) for internal and external systems.
  • Ensure compliance and support audit and inspections as appropriate.
  • Ensure compliance with regulatory, security and other audit requirements at all times.
  • Develop inspection communication skills and ensure compliance trainings are followed consistently and timely.

Qualifications
  • A minimum of 6 years of experience in data systems, SAS programming or data management is required.
  • Experience working with systems covering clinical development within the Pharmaceutical industry is preferred.
  • Experience delivering transformational system implementations yielding a positive Return on Investment (ROI) for organizations is preferred.
  • Experience in managing vendor relationships is required.
  • Knowledge of SAS programming is preferred.
  • Knowledge of SAS LSAF (Life Science Analytical Framework) solutions is preferred.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
  • Strong project leadership skills required.
  • Experience mentoring staff in projects or responsibilities is preferred.
  • Experience working in a global environment is preferred.
  • Must have excellent communication skills
  • Must have the ability to think analytically, be quality results oriented and customer focused.
  • The ability to collaborate and build relationships with internal and external partners in a cross-functional environment is required. 
  • This position will require up to 10% domestic and international travel.
 
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
0635180827