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Data Manager in Fort Washington, PA at Staffing Now

Date Posted: 6/8/2020

Job Snapshot

Job Description

Our client located in Fort Washington, PA has a current and immediate opening for a Data Manager. This is a permanent role.
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.
  • 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.