Clinical Data Associate

Summary of Job Specification

Clinical Data Associate applies data management expertise and computer skills in support of the data management activities of drug and vaccine development programs. May be responsible for the following: managing central and local laboratory data; managing case report form (CRF. eCRF) clinical data; assessing data quality; and performing manual term encoding. In addition, provides documentation that details these work activities based on internal standard operating procedures with guidance from senior staff. Interacts effectively and works closely with people across functional areas within the organization as well as global customers and vendor partner.

Detailed Job Duties and Responsibilities

Study level Clinical Data Management support
Coordinates and performs the collection and processing of CRF data Performs data management activities, which may include any of the following: data receipt, data entry, and initial and final data review, and discrepancy resolution following Clinical Data Management SOP and ICH/GCP practices
Responsible for using manual and automated methods to perform clinical data review and medical review to ensure the overall integrity and consistency of the clinical trial data.
Interacts with investigation sites for data discrepancy resolution at global level.
Encodes unrecognized terminology entered into the database using MedDRA and other dictionaries, resolves encoding data discrepancies, and supports re-encoding of terminology due to vocabulary updates.
Coordinates the collection and processing of laboratory data.
Responsibilities may include: identifying and resolving central and local data quality issues, and maintaining standard central and local data management practices.
Maintains process performance metrics and reviews them periodically with department head to identify areas where efficiency can be improved.
Possibly supports user acceptance testing activities of Clinical Data Management tools
Communicates with customer and partner about project related issues or based on defined communication responsibilities in SOP
May participate in a continuous improvement special project related
Participate in outside normal business hours teleconferences as project requires

Education / Qualifications / Experience / Skills Requirements

B.S. degree in Medical, Pharmacy, Nursing, Biology or related discipline.
Good communication and interpersonal skills.
Strong application skills in computer systems
Detailed oriented
Excellent English, both written and verbal
Minimum of 2 years experiences in Clinical Data Management, Clinical Research or in a clinical or bio medical
Basic knowledge of late stage clinical data management process
Preferred, but not required experience in use of one or more EDC tools or Clinical Data Management System for example Oracle Clinical or Clintrial
Good knowledge of ICH/GCP including, understanding of regulatory requirements and European Directive
Ability to work independently and efficiently
Work effectively in a team
Good analytical skills
Good organization skills
Good presentation skills

Travel
 
Available for traveling, including overnight stays as necessary