J&J Family of Companies Clinical Data Processing Solutions Expert in Leiden, Netherlands
Janssen Research & Development, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Clinical Data Processing Solutions Specialist. This position can be based in Spring House, PA; Horsham, PA; Malvern, PA; Raritan, NJ; Beerse, Belgium or Leiden, Netherlands.
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.
The Clinical Data Processing Solutions Specialist will provide expertise in clinical data processing technologies in order to guarantee support required by the Integrated Data Analytics and Reporting (IDAR) and Quantitative Sciences (QS) organizations. 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 trial teams. Impact processes, project timelines, priorities and functionality of conducting clinical trials and clinical trial software.
Responsibilities will include:
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.
Provide direction to external vendors and contractors.
Provide guidance and expertise to the IDAR teams using data processing solutions.
Remain current on the following solutions part of the portfolio: SAS drug development platform; SAS programming and support processes; customized web platform to automate clinical data management activities; conversion tooling to translate electronically captured data into datasets for regulatory submissions and analysis.
Share expertise to support the clinical data delivery and analysis teams and Clinical Research Organizations (CROs) by organizing trainings, Question and Answers sessions, 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 in collaboration with the targeted user community; Develop guidance materials and training for integrating the new tools into the business processes.
Identify and participate 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 level 1/2/3 support across Global Clinical Development Organization (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.
A minimum of a Bachelor’s degree in Engineering, Science, Computer Science or related discipline is required. Master’s degree preferred.
A minimum of 1 year of experience with data systems and/or data warehousing is required.
Experience with clinical data systems preferred.
Technical knowledge in software solution development is preferred.
Programming experience is preferred.
Experience with SAS is preferred.
Experience with Java is preferred.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
Strong project leadership skills preferred.
Global experience 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.
United States-Pennsylvania-Spring House
North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC. (6084)
Clinical Data Management