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Job Details


Clinical Data Manager
Fort Washington, PA  Posted: 9/17/2019

Details:

Great Opportunity with a Leading CRO for a Clinical Data Manager! Option for 2 days work from home. 
 
Title: Clinical Data Manager

Duties & Responsibilities:
Key responsibilities and skills may include, but are not limited to:
 Participate in the review of Clinical research documents (e.g., Protocols, Case Report Forms).
 Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and
ensures DMP is followed according to study design and requirements.
 Create and maintain Data Validation Plan.
 Create Data Entry Guidelines.
 Create eCRF Completion Guidelines.
 Create Data Transfer Specification.
 Develop and review Case Report Form (CRF), electronic and/or paper.
 Develop database (DB) clinical trial data specifications, including CRF annotation, edit
rules/checks, and query logic and data validations.
 Perform external data reconciliation in collaboration with programmers.
 Develop test scripts and execution logs for User Acceptance Testing (UAT).
 Perform training on study trials and create user guides.
 Perform database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim
review, and or final database lock.
 Coordinate the archiving of study databases and related documents.
 Database audit.
 Perform SAE reconciliation.
 Perform other activities as required.
 Provide mentorship to junior members.
 Working with project manager and cross functional team members to maintain project timeline
and overall quality of deliveries.
 
Essential Skills Required & Education:
 Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or
nursing degree.
 
Requirements:
  • At least 3 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
  • Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Working knowledge of Clinical database applications.

Job ID#:

6737

 



 

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