CLINICAL DATA TEAM LEAD

Top CRO in Raleigh, NC is seeking a Senior Clinical Data Associate with EDC experience on a 6 month contract.

 

Responsibilities:

Performs clinical data management and review of all study patient information captured during the conduct of a clinical trial.  Ensures the data captured and stored in the clinical study database is an accurate and complete representation of the activities, experiences, and events occurring during a clinical study.  Works on a project team and complies with all Standard Operating Procedures (SOPs), regulatory guidelines and directives, and study specific plans pertaining to collection, review and management of clinical study data.  Clinical Data Associate III is responsible for the job responsibilities at that level as well as the job responsibilities at the Clinical Data Associate levels below it.

 

REQUIREMENTS:

Lead experience with budget/timeline responsibilities on multiple studies.  Communication with sponsor client.  Requires a minimum of a B.S./B.A. degree in the biological sciences or related disciplines in the natural science/health care field or equivalent plus a minimum of 5 years directly related data management experience, or MA/MS and 4 years of health care or clinical research experience with 5 years directly related data management experience. or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job. Oracle Clinical is a must.  Working knowledge of medical terminology, clinical data, and Good Clinical Practices is required.  Requires effective oral and written communication skills, presentation skills, and attention to detail.  Experience with relational database management software systems is required.  Requires proficiency in Word, Excel, and Email. Ability to multi-task under deadlines and work as part of a multi-disciplinary team as well as independently. Ability to be flexible and adapt to change.