Clinical Data Manager Job at cGxPServe, Worcester, MA

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  • cGxPServe
  • Worcester, MA

Job Description

Responsibilities:
  • Develop and implement data management plans for clinical trials.
  • Ensure data quality and integrity throughout the trial.
  • Develop and maintain study-specific data management documents such as data management plans, annotated CRFs, and database specifications.
  • Collaborate with cross-functional teams to identify project priorities and timelines.
  • Manage data quality assurance procedures and perform quality control checks.
  • Ensure adherence to regulatory compliance by following relevant guidelines and standard procedures.
  • Contribute to the development of standard operating procedures (SOPs) and work instructions.
  • Prepare and review database validation and user acceptance testing.
  • Perform database lock activities, including data reconciliation and database closure.
Requirements:
  • Bachelor's degree in a relevant field such as life sciences or a related discipline.
  • Freshers in clinical data management of drug development programs.
  • Familiarity with regulatory guidelines such as ICH/GCP and FDA regulations.
  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and organization skills.
  • Good interpersonal and communication skills to work effectively in a team environment.

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