Lead Data Manager

Randstad USA • united states, united states, us • 1m ago

Responsibilities:

General oversight of the Data Management aspects of the study including ensuring DM reviews and coding are up to date with study expectations from study initiation through database lock.
Development and maintenance of the eCRF. This includes designing mockups and edit checks for the programmer, planning and conducting UAT for the initial build and any mid-study updates, setting up maintaining eCRF Training within the training module.
Development and maintenance of eCRF guidelines, Data Management Plan/Review Guidelines, etc.
Attendance to weekly Clinical Operations meetings to represent and present the DM status (including updating slides for these meetings). Escalate site issues that have not been resolved.
Write Data Management Topics via Newsletter
Filing of any DM related eTMF documents in a timely manner
Working with external vendors with data feeds to ensure Data Transfer Agreements (DTAs) are in place
Working with external vendors to ensure any needed data reconciliation is adequately completed
Conducting general DM review for select sites
Oversight and training of the general Data Management Reviewer team member(s)

Education & Qualifications:

BS/BA degree in a biological science, health-related or computer science field.
Generally, 6 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 4 years experience as Data Manager, with progressive levels of experience with varying study types and phases.

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