Senior Clinical Data Manager - San Francisco, CA - Contract Opening

Performs data management actiivites under the direction of the Lead Data Managers and Director of Data Management in a predominantly outsourced Data Management model: reviews edit specifications and database setup and performs UAT activities on clinical databases; performs data review; reviews work of CROs and tracks deleverables with respect to study timelines. Contributes to the solution process for data issues. Performs data transfers and maintains the internal data respository of clinical data. Data Quality: reviews data, including data listings, metrics reports, and data trends. Reports trends to Clinical Operations colleagues and management; escalates potentially troublesome trends; works with Biometrics to understand their analysis requirements and their data quality requirements; may generate ad-hoc reports according to ability. Maintenance of data library: regularly refreshes internal data respository from data extracts and transfers from external vendors; archives data; QAs data transfers, documents data transfers; performs transfer of files to Biometrics from data repository. Organizes CRFs and eCRFS for inclusion in submission documents. Clinical Database setup and modification: reviews trial data specifications, including eCRF design, database requirements, eCRF completion guidelines and edit rules in collaboration with cross functional groups. Attends cross-functional review meetings for the data specifications and eCRF design; Performs UAT activities. All or part of these duties will be performed in collaboration with contracted CROs. Data standards: stays current with development and current thinking about data collection using standard instruments for assessing Alzheimer's Disease; stays current with data collections standards with respect to CDISC, especially CDASH standards. Perform other work related duties as assigned.



If interested, please contact Dawn Duggan at dduggan@a10clinical.com or 919-674-3342