Clinical Data Manager

Clinical Data Manager

Our client, a Successful and Thriving Medical Device company, has an opening for a Clinical Data Manager.  The Clinical Data Manager is a lead member of the clinical research team responsible for data management activities across multiple trials. Activities include assisting in data entry, query processing, site management, data reporting and other data management activities in support of clinical trial projects. Perform data management activities on both paper based and Electronic data capture (EDC) studies.

Major daily duties include:

•CRF data review, preparation for entry, query processing, discrepancy management, adhoc reporting and listing generation.

•Develop study specific database requirements and edit check requirements with the help of Clinical Research Associates (CRA) and field monitors.

•Create and maintain data management trackers and checklists for multiple projects.

•Set-up and keep track of new sites, users across studies for EDC studies.

Other Duties include:

Assist in CRF design/development, database design and validation activities (for paper based trials).

Support with EDC study validation, user acceptance testing and implementation, data verification audit listings and other audit activities, design case report forms.

Build database using ORACLE Clinical and Remote Data Capture.

Assist in overall project tasks such as generating CRF completion guidelines, process flowcharts, Standard Operating Procedures (SOPs), work instructions and training guidelines.

Support the team in any study startup and closeout activities including final report data QC.

Participate in project meetings to give a status update to project managers and upper management.

Assist in preparation of study material for investigator, study coordinator and monitor meetings.

Work primarily within Clinical Affairs interact with the Quality and Regulatory Affairs Staff, working on  multiple clinical studies at one time.

Five to eight years industry experience; minimum 2 years experience in medical device and/or pharmaceutical data management environment.

•Computer literacy in MS Word, Excel, PowerPoint, Access, ORACLE Clinical, RDC, SAS and CRF design tools.

Minimal travel may be required.