Senior Clinical Data Manager Job at cGxPServe, San Francisco, CA

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  • cGxPServe
  • San Francisco, CA

Job Description

Responsibilities:
  • Participate in clinical meetings with Sponsor and KPS personnel as required.
  • Take necessary actions to ensure data management deliverables are met.
  • Establish rules and procedures for secure and responsible data sharing with executives.
  • Manage data management resourcing for all clinical studies, as required.
  • Prepare documents and ensure tools are arranged to allow for data capture and data cleaning.
  • Ensure delivery of a clean and secure database.
  • Instruct, communicate, coach and mentor others on data management procedures.
  • Ensure compliance with EMEA, FDA, and ICH GCP regulations and policies.
  • Ensure compliance with appropriate Sponsor SOPs.

Requirements:

  • BS/BA or master's degree with preference in a biological, analytical/data, health related, or computer science field.
  • 7-10 years related experience in a pharmaceutical or CRO setting.
  • 5 years' experience in Data Management.
  • Knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.).
  • Experience working on studies both insourced or outsourced to a CRO.
  • Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite).
  • Strong management and motivation skills.
  • Ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines.
  • Extensive and comprehensive knowledge of international ICH GCP guidelines.
  • Excellent interpersonal, written, and oral communication skills.

Job Tags

Work at office,

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