Ardea Biosciences, Inc. a San Diego based biotechnology company, is focused on the development of small molecule therapeutics for the treatment of serious diseases. It’s an exciting time at Ardea, as we have a gout product moving to Phase 3 and additional Phase 1-2 activity. As a result of our growth, we have several positions open including 2 Clinical Data Managers (Contract).
The contract CDM is responsible for the oversight of Data Management activities performed by Contract Research Organizations (CROs) and review of 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.
- Leads the design of 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.
- Oversees 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.
- Other duties as deemed necessary
Interested parties can review detailed job descriptions and apply on-line at: www.ardeabio.com/careers/ or submit your resumes to [email removed]
- Bachelor’s Degree in Life Sciences or related field.
- Minimum of 7 years’ experience in Clinical Data Management, including support of Phase 3 studies.
- Experience in CRO management/oversight.
- Experience with EDC system development and deployment.
- 3 years ago - save job