Clinical Data Manager (Contract)
Alcock & McFadden - San Diego, CA

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Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea is seeking a Contract Clinical Data Manager to join its' dynamic team.
The Contract Data Manager will support Data Management activities and review clinical data for clinical studies conducted by Ardea.

Responsibilities include:
  • Periodically reviews the effectiveness and quality of the Data Management work performed by CROs and provides feedback to correct issues; suggests improvements.
  • Ensures that Data Management deliverables from CROs adhere to established Ardea standards and scope of work.
  • Develops Case Report Forms (CRFs) and other data collection instruments for clinical studies.
  • Reviews all deliverables for Electronic Data Capture (EDC) and electronic Patient Reported Outcome (ePRO) system development and implementation and provides feedback to the clinical team and the CRO/EDC/ePRO vendor.
  • Participates in testing of EDC and ePRO applications for clinical studies.
  • Reviews all deliverables from CROs, such as Data Management Plans, based on the study Protocol and (CRF), and provides feedback to the clinical team and the CRO/EDC vendor.
  • Provides support to study teams for all Data Management issues and questions and suggests solutions.
  • Develops summaries, presentations and spread sheets of clinical data and/or data issues as needed to fulfill requests from the clinical team or development partner.
  • Reviews Study Tables, Listings and Figures and provides feedback on data and programming; summarizes comments from the clinical team and provides to the CRO.
  • Reviews Statistical Analysis Plans in comparison to the study Protocol and CRF and provides feedback to the clinical team and the CRO.
  • Reviews Clinical Study Report drafts and shells for accuracy and completeness and provides feedback to the clinical team and the CRO.
  • Carries out job responsibilities and assignments safely and maintains a clean and safe work area.
  • Bachelor's Degree in Life Sciences or related field
  • Minimum of 5 years experience in CDM, including support of Phase 3 studies
  • Experience in CRO management and oversight is preferred
  • Experience with EDC system development and deployment
Interested parties please apply on-line at: www.ardeabio.com/careers or recruit@alcockmcfadden.com
No third party recruiters please

Alcock & McFadden - 18 months ago - save job - block
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