Lead Clinical Data Manager

Provides leadership, mentoring and training of all lower level Data Management staff assigned to work on their projects

Some business development work may be required

Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal

Writes, updates and reviews and approves all required trial data management documentation, documents

Monitors the progress of all data management activities for the project to ensure that project timelines are met

Involved in building effective DM vendor relationships for all assigned studies

Executes and/or distributes DM and study listing, reports as required

Involved in RFP development, some contract negotiation and selection of DM and/or technology, as necessary. Escalates issues with proposed solutions, as necessary

Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards as needed

Skills:

Excellent data manager skills in a pharmaceutical or CRO working in a FDA regulated environment

Good knowledge of ICH, FDA, and GCP regulations and guidelines; knowledge of CDASH, SDTM and CDISC

Good project management skills with the ability to multitask

Experience working with EDC system

Good technical skills (SAS, Clintrial, Oracle, SQL preferred)

Proven track record in leading DM team to support multiple studiesTo find out more about Real Staffing please visit www.realstaffing.com