Abbott Clinical Data System Analyst II in Sylmar, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Working under general supervision, 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. Ensuring the integrity of the processing and evaluation of clinical data, analyst closely collaborates with the Clinical Affairs Organization, Data Management and Systems Development groups within the Clinical Data Operations organization. Participates in the collection of project requirements analyzing business needs. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in proactive planning, organizing and performing work; monitors performance and effectively communicates status within area of responsibility. Assures that quality of services meets internal and external customer requirements. May serve as a project manager in various projects.
Proficient understanding of Clinical Trial Management Process and regulations that apply, engages professional association, seeks continuing education about SJM 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. Practices effective communication, active listening and team work.
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
Proficient 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
Proficient ability to communicates well with all levels of employees including peers, study teams and management to support studies and goals
Proficient experience in training to various sized audiences on applications and/or reports including training set-up, training documentation, live training, training recordings, utilizing training tools including PowerPoint
Will be Subject Matter Expert (SME) in one or more applications
Proficient Support Line contact addressing requestor’s issues in a timely and efficient manner delegating to proper 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.
Proficient knowledge and complies with Good Clinical Practices (GCP), US Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procures and processes
Performs other related duties and responsibilities, on occasion, as assigned
Bachelor Degree in Computer Science, Health Sciences, related field or equivalent
Typically three plus years’ experience working in a clinical research environment and/or healthcare industry experience
Organizational and proficient project management skills, as well as attention to detail
Program Management Professional (PMP) certification is desired
Highly skilled with Microsoft office products including Word, Excel, and Access
Proficient ability to work with database management systems
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 Clinical or equivalent
Proficient knowledge and experience building/customizing Clinical Trial Management Software Applications
Ability to work in a highly matrixed and geographically diverse business environment.
Proficient ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong oral and written communication skills
Ability to meet deadlines and handle multiple assignments in a timely manner, and meet assigned deadlines.
Ability to travel approx. 5%
Basic understanding of human physiology or any prior involvement with medical field
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com