|Job Category||Professional Consulting|
|Position Type||Full Time|
|Application Deadline||October 31, 2020|
|Experience Required||5+ years|
RESPONSIBILITIES:Responsible for hiring and retaining highly qualified data management staff and for providing career coaching, growth, and personal development. Accountable for staff development.Leads a team of Clinical Data professionals to manage projects that require implementing new, updated and/or enhanced systems responsible for data collection for clinical studies.Supports new and existing study database set-up; 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.Oversees the development of CRFs, edit check specifications, and additional data collection requirements required for tracking and analysis. Experience with Software Development Lifecycle (SDLC).Manages the process of user requirement analysis and user acceptance testing from the creation of test scripts through execution; including providing any related findings that are applicable throughout the testing phase.Manages processes to ensure data integrity leveraging appropriate data management processes (e.g., protocol compliance reporting, querying for missing or discrepant data, evaluating data outliers, performing data quality checks, etc.).Manages custom query requests and reporting from clinical databases, Oversees the process and provides other departments with queries.Work with vendors to assess new technologies and help to drive and align the implementation. Leads development and quality control (QC) of data management documents including data management plans, data review guidelines, database validation protocols, and departmental standard operating procedures (SOPs).Ensures compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
REQUIRED EDUCATION AND EXPERIENCE:Bachelor of Science in related field is required.Minimum of 8 years of experience.SCDM certification would be considered an asset.In vitro diagnostics/medical device company experience or relevant systems experience in a clinic/hospital/university environment is preferred. A minimum of four plus years of demonstrated experience at a supervisory/managerial level preferred.Advanced personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc.Software and Systems/Hardware experience with good understanding of key industry leading software platforms (Microsoft, R, SAS, etc.) including some level of certification desired.Knowledge and experience building/customizing Clinical Trial Management Software Applications.Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
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