Clinial Data Manager - EDC / Inform / Cdisc - Vendor Management

The Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock, for development programs. This individual will be a point of contact with CROs and other external vendors for all issues related to data management. Emphasis will be on coordinating and reviewing listing and outputs for an internal review of the data.

Specific responsibilities include:

*Data cleaning activities including listing review, external data reconciliation and data review

*Reviewing and finalizing all DM related documents including Data Management Plan, edit check specifications, completion guidelines, and CRF design

*Handling of external data and facilitating data transfers to internal and external stakeholders

*Communicating with external vendors to define required file format and content specifications for electronic files

*Overseeing database quality control activities

*Working with the other functional groups within the project team (e.g. Biostatistics, Statistical Programming, Clinical Investigations, Clinical Operations, Research and Development)

*Participating in the development and maintenance of SOPs and process guides related to data management activities

Minimum Requirements:

*A BA or BS degree with a minimum of 5+ years of directly-related clinical data management experience; 5 years preferred

*Skilled in the use of EDC systems (Rave preferred) and reporting tools

*Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines

*Detailed understanding of project planning and management methods

*Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment

*SAS programming knowledge is highly preferred

To find out more about Real Staffing please visit www.realstaffing.com