Clinical Data Solutions Analyst

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Johnson & Johnson is currently recruiting for a Clinical Data Solutions Analyst. We’re currently looking for a dynamic personality with an eye for detail who loves programming and science in a multi-national and multi-cultural environment. The Clinical Data Solutions Analyst is positioned within the Data Processing Solutions Team and part of Enabling Business Information Solutions (EBIS) department in the Pharmaceutical organization of Johnson & Johnson. The role will bring expertise in clinical data processing technologies supporting the Integrated Data Analytics and Reporting (IDAR) and Quantitative Sciences (QS) organizations. This individual will build additional knowledge and gain experience in clinical data management and programming language. The person will take ownership of projects to build new and innovative solutions for the trial teams as well as improve existing solutions. The individual will have an impact on processes, project timelines, priorities, and functionality of conducting clinical trials and clinical trial software. Following solutions are part of the portfolio: Data Management Environment (DME) platform and/or Statistical Programming Environment (SCE) platform and support processes SAAS based solutions tailored to the life sciences industry Customized web platforms to automate clinical data management activities like clinical standards library management, clinical study specification setup, and clinical data validation Conversion tooling to translate electronically collected data into datasets for regulatory submissions and for analysis and for consumption by various downstream applications Digital Health Platforms and integrations to directly measure wearables and automate parts of the Electronic Health Records in hospitals Principal Responsibilities: Interact with Data Delivery and Data Analysis clinical teams, Biostatisticians, Medical Writing, and external vendors. Provide direction to vendors and contractors. Be the specialist and guide the IDAR teams using data processing solutions. Share expertise to support the clinical data delivery and analysis teams and Clinical Research Organizations (CROs) by coordinating and giving training, Question and Answers sessions, and coordinating direct support when needed Develop tools and programs to be used by the global user community Deliver on medium complexity projects Lead the business analysis and build user requirement specifications Participate in and contribute to the deployment and implementation of new solutions Conduct and lead User Acceptance Testing in collaboration with the targeted user community Develop training materials and documentation required for integrating the new tools into the business processes Identify and participate in process, system, and tool innovation 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, including cloud-based systems. Ensure compliance and support for audit and inspections as appropriate and with regulatory, security, and other audit requirements at all times while training is followed consistently and in a timely manner. Develop inspection communication skills on the job Principal Relationships: The Clinical Data Solution Analyst will collaborate closely with data management, statistical programming, and/or IT teams. Individuals may take ownership to give directions to vendors and contractors. Qualifications Education and Experience Requirements: A minimum of a Bachelor’s degree in Engineering, Science, Computer Science or related subject area is required. A Master’s degree is preferred. At least 1 year of experience with data systems and/or data warehousing is required. Proficiency in Microsoft Office is required. Experience with clinical data systems preferred. Technical knowledge in software development is preferred. Programming experience is preferred and more specifically, with SAS and R. Strong project leadership skills are preferred. Experience in a global environment is a plus. Other: Must have superb communication skills. Must have the ability to think analytically, be results-oriented in accordance with the highest quality standards, and always with the customer in mind. This role will require building strong partnerships and multi-functional collaboration across multiple teams & departments and with external partners. This position will require up to 10% domestic and international travel Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Primary Location Belgium-Antwerp-Beerse- Other Locations North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Chesterbrook Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105973514W