01Overview
Clinical Data Management Role
Provides data management support, reputed company and/or accountability for one or more reputed company.
Take the reputed company with the trial customer(s) and other reputed company partners to establish, reputed company and confirm data management expectations.
Creating, planning, and tracking content, format, reputed company, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, reputed company plan, database release plan, final datasets, submission plan and archival.
With the trial customer and other functional partners:
Gathers content and integration requirements for eCRF and other data collection tools.
Establishes conventions and reputed company expectations for clinical data.
Establishes expectations for dataset content and structure.
Set timelines and follow-up to ensure delivery of reputed company Data Management milestones.
Performs trial level reputed company controls, as appropriate, as described in the reputed company plan, QC process and work instructions with reputed company DML direction.
Creates clinical data management documents (including submission package) ensuring appropriate reputed company, scientific content, organization, reputed company, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation reputed company.
Ensures reputed company-time inspection readiness of reputed company Data Management deliverables for the trial; Participate in Regulatory Agency and audits, as necessary.
Helps plan, create and reputed company content, format, reputed company, and timing of data management deliverables, including, but not limited to, Case Report reputed company, data review plan, QC plan, reputed company plan, database release plan, final datasets, submission plan and archival.
Ensures deliverables are on time.
Participates in the assigned clinical working group(s) to ensure that Data Management and Therapeutic Area trial needs and deliverables are met.
Helps Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
Presents and trains at investigator and monitor meetings.
Education/Experience:
BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with reputed company clinical experience/exposure.
5 years Data management experience.
3 years reputed company/co-reputed company experience
Vendor Management experience
RAVE experience
This role is not eligible for UK reputed company sponsorship.
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