What are the responsibilities and job description for the Clinical Data Systems Analyst II position at Viltis?
Clinical Data Systems Analyst II
Position Summary :
The Data Analyst is responsible for various special projects related to the data systems aspects of the clinical studies conducted. These special projects will include implementing new, updated and / or enhanced systems that are responsible for data collection for clinical studies as well as providing assistance to multiple customers globally, externally and internally.
This person will be ensuring the integrity of the processing and evaluation of clinical data, analyst closely collaborates with the Clinical Affairs Organization, Data Management and Systems and Development groups within the Clinical Data Operations organization. The Data Analyst is responsible for pulling data to support trending of product complaints and medical device reports utilizing data that resides in the complaint handling database for all product lines. This will include detailed data reports prepared for routine trending, senior management reviews, ad-hoc requests, and cross-functional requests as needed (e.g. Regulatory, Quality Engineering, R&D).
Duties :
Proficient understanding of Clinical Trial Management Process and regulations that apply, engages professional association, seeks continuing education about company devices and therapies.
With general supervision, manages projects that will require implementing new, updated and / or enhanced systems responsible for data collection for clinical studies as well as assistance with multiple customers
globally, collaborating within Global Clinical Affairs as well as with other external and internal customers.
May assist leadership with project prioritization and development of clinical technology strategy and communicate when deadline is not able to be met and solution on steps going forward.
Proficient ability to troubleshoot process-related items and the direct affects that it has on the applicable systems; applies out-of-the-box thinking to solve application and / or report requests from customers and Clinical Data Systems.
Actively supports and applies best practices and established standards; ability to utilized project management skills to work with multiple projects through communication, leading meetings and maintain any notes and meeting deadlines that are required.
Actively supports, leads and collaborates with other team members to complete projects. Performs as liaison between internal and external customers and the clinical data systems software engineers.
Proficient ability to analyze user requirements, procedures, and problems and to gather, organize, write and produce project requirements and specifications documentation that clearly states what is needed for the application; including leading meetings / discussion with direct manager regarding systems and / or processes, take meeting minutes and providing communication regarding the progress of project.
Proficient ability to understand and perform user acceptance testing from the creation of test scripts through execution; includes providing any related findings that are applicable throughout the testing phase.
Contribute in writing technical documentation and manuals. Proficient ability to communicate customer-requested changes to the developer regarding the system, as well as communicate any issues with development to the system directly to the external and / or internal customers.
Ability to discuss all assigned projects with general supervision and be able to answer any detailed question regarding the project impacts on other systems.
Requirements :
3 years working in a clinical research environment and / or healthcare industry experience.
Proficient knowledge of database terminology and technology. Preferred knowledge of Relational Databases and demonstrated ability to generate queries using Query languages like Structured Query Language (SQL).
Proficient knowledge and experience in supporting the building of clinical trial databases using Oracle.
Proficient knowledge and experience building / customizing Clinical Trial Management Software Applications.
Proficient Support Line contact addressing requestor’s issues in a timely and efficient manner delegating toproper CDSA as needed.
Proficient ability to communicate technical items to non-technical audiences.
May perform proficient Global System Librarian responsibilities.
Proficient understanding of clinical data collection tools with an emphasis on Oracle Clinical and Oracle Clinical’s Remote Data Capture (RDC) system
Proficient ability to support new and existing study database set-up (RDC and paper); understanding of Case Report Form (CRF) design, edit check specifications and system components that relate to the design and integrity of the database for data collection of a study.
Proficient experience with Software Development Lifecycle (SDLC). Follows and provides input to Departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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