Principal Clinical Data Systems Specialist - REMOTE

Jobgether

10h•$115,600 - $245,800•Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Clinical Data Systems Specialist. In this pivotal role, you will leverage your extensive experience in clinical data management to support core teams in the execution of global clinical trials. Your expertise will greatly impact the management and administration of clinical data systems, ensuring compliance with regulatory standards and enhancing data integrity. This remote opportunity allows you to contribute significantly to the advancement of clinical studies and collaborate effectively with cross-functional teams worldwide.

Requirements

Bachelorâs degree required.
8+ years of clinical data management experience in medical device or pharma.
Proven expertise as a Medidata Rave super user, including URL management and database build.
Hands-on experience with PMV clinical studies, including EDC design and CRF development.
Strong knowledge of data collection, reconciliation, processing, coding, reporting, and validation.
Deep understanding of clinical data management systems and regulatory standards.

Responsibilities

Manage administration of the Rave URL activities, including Report Administration, eLearning, User Roles and Core Configuration.
Provide technical support for Rave study development, Rave URL modules, and site management/user access.
Lead development of study database, programming clinical databases according to CRF Specifications and performing edit checks.
Support global library by programming forms and edit checks according to data collection standards.
Lead Clinical Data and SAS Programming activities.
Create and maintain Clean Patient Trackers, dashboards, and operational reports.
Serve as system administrator to grant user and site access within Medidata Cloud Administration.