Clinical Data Manager

POSITION SUMMARY:

The Clinical Data Manager is responsible for effectively managing CROs and vendors and “growing” the small clinical data management department.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•Analyzes operational data requirements to design and implement systems necessary to collect and maintain data
•Resolves data input, storage and /or retrieval problems and to design solutions and modifications
•Ensures that databases meet requirements for the entry and reporting of clinical data
•Performs detailed data reviews, verify data input, and generate queries
•Contributes to the design of protocols, including the ability to define what and when data are to be collected
•Designs and approves Case Report Forms
•Trains clinical research associates to help improve the quality of the data being collected
•Manages CROs and vendors
•Writes Clinical Data Management SOPs
•Performs QC as requested
•Other duties as assigned
REQUIREMENTS
QUALIFICATIONS AND REQUIREMENTS:

•Bachelor’s Degree or one to two years related experience and/or training; or equivalent combination of education and experience
•Experience in protocol development, CRF design, and database systems
•Knowledge of EMEA and ICH regulations and CDISC and FDA guidances
•Proficiency with Microsoft Office and MedDRA
•Knowledge of current technological developments/trends in data management, database construction, management, and retrieval methods
•Ability to create edit checks, data capture and input specifications
•Communicate effectively, both orally and in writing
•Knowledge of SAS and GCP a plus