The Clinical Data Analyst ensures the successful end-to-end operation of clinical data transfer process. The role supports the optimal planning and execution of all activities associated with data transfers. This role serves as the data management expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Work with the project management, Laboratory staff and GxP Systems team on study start up activities, including data entry, database screen testing, edit/check software tool development and perform testing
Work in conjunction with study project managers and technical laboratory staff to understand data transfer specifications and study timelines to help assess and ensure that proposed solutions satisfies requirements, timelines, broader data management and BioPharma goals.
Work with CDM, GxP systems and Project Management teams to facilitate agreements, maintain project timelines, drive project completion, escalate issues as appropriate and maintain study data transfer deadlines.
Communicates with Project Managers, MIRTH team, LIMS team and test method leads on a regular basis to meet data management deliverables on the multiple projects and ensures milestones meet timeline and quality deliverables
Communicate data issues and/or query trends to Sponsor and/or project team, as appropriate
Assess issues / generate solutions in data handling created by the changing requirements in clinical data processing.
Escalate any potential or actual issues to supervisor, project team, and/or Sponsor in a timely manner, and follow issues through to resolution
Assists in User Acceptance testing
Review clinical data as per SOP, protocol, and study specific guidelines
Handles confidential material and adhere to data security and confidentiality requirements
Provides status updates related to project tasks to management as necessary
Other Duties as assigned
Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions
Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions