Senior/Principal Clinical Data Manager

Tuscon  ‐ Onsite
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Keywords

Description

SPECIFIC RESPONSIBILITIES
The Clinical Data Manager will:
  • Review protocols for proper data capture including Case Report Form design. Able to perform a thoroughly detailed review of CRF data requirements.
  • Designs CRFs and creates annotated CRF and CRF completion guidelines.
  • Develop a Data Management Plan that outlines CRF flow, data queries, manual checks, and data listings needed to facilitate Data Management activities throughout a clinical study.
  • Leads and coordinates the design and testing of clinical study databases to match CRFs according to company standards. Able to resolve database issues with team members
  • Supervise and assist with clinical data entry as needed
  • Setup databases for individual study protocols
  • Develop data edit check specifications and run data listings as required
  • Generate data query forms to be resolved at investigational sites and enter resolutions into database
  • Perform coding of adverse events, concomitant medications and medical history
  • Import electronic data into the database
  • Perform database lock and freeze activities per company SOPs
  • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
  • Provides guidance and monitors the progress of data management activities with CROs or other vendors
  • Ability to present clinical study CRFs and CRF completion instructions at investigator meetings and other trainings as needed.
  • Participate in regular team meetings and provide input when appropriate
  • Provide input into the development of data management SOPs and processes
  • Interact with CRAs, programmers, study managers and statisticians in creating an clinical study database, performs data quality assurance activities, and manages the resolution of data queries
  • Assist in database upgrades/migrations including performing User Acceptance Tests
  • Ability to write or review Data Management work instructions and SOPs
  • Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
  • Ability to maintain study workbooks and data management files
  • Assist with the training of new employees and/or contractors
Start date
08/2014
From
Real Staffing
Published at
07.08.2014
Project ID:
754329
Contract type
Freelance
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