Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The Contract Data Manager will support Data Management activities and review clinical data for clinical studies conducted by Ardea.
• 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
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.