What are the responsibilities and job description for the Clinical Data Systems Analyst II position at Bioethic?
Clinical Data Systems Analyst IIPosition Summary : The Clinical Data Systems Analyst II is responsible for various special projects related to the data systems aspects of clinical studies. This includes implementing updated and enhanced systems for data collection and providing assistance to multiple customers globally, both externally and internally. The Analyst ensures the integrity of processing and evaluating clinical data and collaborates closely with the Clinical Affairs Organization, Data Management, and Systems and Development groups within Clinical Data Operations. Responsibilities include pulling data to support trending of product complaints and medical device reports utilizing data from the complaint handling database for all product lines, including preparing detailed data reports for routine trending, senior management reviews, and ad-hoc requests.Duties : Proficient understanding of Clinical Trial Management Process and regulations; engages with professional associations and seeks continuing education about company devices and therapies.Manages projects requiring implementation of new, updated, or enhanced systems for data collection while assisting multiple customers globally.Assists leadership with project prioritization and development of clinical technology strategy; communicates deadlines and solutions when unable to meet them.Troubleshoots process-related issues and applies innovative thinking to solve application and report requests from customers and Clinical Data Systems.Supports and applies best practices and established standards; utilizes project management skills to manage multiple projects, lead meetings, and maintain required documentation.Collaborates with team members to complete projects; acts as a liaison between internal and external customers and clinical data systems software engineers.Analyzes user requirements and produces project requirements and specifications documentation; leads discussions with management regarding systems and processes.Conducts user acceptance testing, creating test scripts and executing them, providing findings throughout the testing phase.Writes technical documentation and manuals; communicates customer-requested changes and issues with development to relevant parties.Discusses all assigned projects with general supervision and addresses detailed questions regarding project impacts on other systems.Requirements : Proficient support line contact addressing requestor’s issues in a timely and efficient manner.Ability to communicate technical items to non-technical audiences.May perform Global System Librarian responsibilities.Understanding of clinical data collection tools, particularly Oracle Clinical and Oracle Clinical’s Remote Data Capture (RDC) system.Experience in supporting new and existing study database setup (RDC and paper); understanding of Case Report Form design, edit check specifications, and system components related to database integrity.Experience with Software Development Lifecycle (SDLC); follows and provides input to departmental SOPs and guidelines.Supports all company initiatives as identified by management, in support of Quality Management Systems, Environmental Management Systems, and other regulatory requirements.#J-18808-Ljbffr