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Provides data management support, oversight and/or accountability for one or more clinical trials.
Take the lead with the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations
Creating, planning, and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight 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 quality expectations for clinical data.
Establishes expectations for dataset content and structure.
Set timelines and follow-up to ensure delivery of all Data Management milestones.
Performs trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML direction.
Creates clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and audits, as necessary.
Helps plan, create and track content, format, quality, and timing of data
management deliverables, including, but not limited to, Case Report Form, data review plan, QC plan, oversight 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 professional clinical experience/exposure.
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