Clinical Data Manager

DATA MANAGER

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our clients is dedicated to making a major positive impact on the lives of people with serious diseases and is seeking to add a contract Data Manager to their team in Cambridge, MA.

 

JOB SUMMARY:

Working with a leading biotech company and in support of major product development, this candidate will be interacting closely with clinical team members, contract research organizations (CROs) and external vendors to ensure that all data related activities are performed according to protocol, GCP, and/or approved SOPs.

 

RESPONSIBILITIES:

· Review of clinical data to ensure consistency, integrity and accuracy.

· Review and analysis of clinical data using data management systems in place (Oracle Clinical/ Clintrials).

· Query investigational sites regarding omissions, errors or inconsistencies.

· Develop project specific guidelines relating to CRF Completion Instructions, Data Review Guidelines, Annotated CRFs, etc.

· Work with project managers to determine, execute, review and advise on appropriate data management applications for each project assigned.

· Assist in organization, maintenance and archival of clinical study data.

 

QUALIFICATIONS:

· Minimum of 3 years of pharmaceutical data management experience.

· Oncology data management experience required.

 

EDUCATION:

· BS preferred.

 

KEYWORDS:

Data management, CRF, Data Review, clinical trials, biotechnology, pharmaceutical, data, quality, MedFocus