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Clinical Data Manager
Clinical Data ManagerKatalyst Healthcares and Life Sciences • Phoenix, AZ, United States
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Clinical Data Manager

Clinical Data Manager

Katalyst Healthcares and Life Sciences • Phoenix, AZ, United States
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  • [job_card.full_time]
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Responsibilities:
  • 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 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.
  • The 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.
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Clinical Data Manager • Phoenix, AZ, United States

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