Clinical Data Management Coordinator

The Clinical Data Management Coordinator (CDMC) for major pharmaceutical client in Indianapolis, IN

 

CDMC is accountable for development and implementation of data management processes to ensure optimal design, global consistency and quality of a clinical trial database. The CDMC is responsible for providing therapeutic area data management input and owning data capture system creation during study development, developing and implementing data standards, developing study specific strategy for efficient data review, and implementing new technology and processes to increase data management capacity, capability and quality for its customers.

 

Position Responsibilities: Designs and develops study documents: Case Report Forms (CRFs), CRF Instructions, Electronic Edits, Paperflow and Data Validation Plan Proactively conducts on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies (using Comprehensive Data Review techniques).Responsible for correcting errors and discrepancies through the site query process, for documenting permanent data issues, and routinely communicating issues with team members. Understanding of the relationship between the study protocol, statistical analysis plan, CRFs, and data validation plan. Delivering a quality locked database for analysis.

 

Minimum Requirements Bachelors degree or equivalent experience required. Strong project management skills across study development, maintenance, and datalock processes.Proficient in computer technology used in an office environment (word processing and spreadsheet programs, for example. Excellent analytical and critical thinking skills required, including a high attention to detail and accuracy.Excellent written and verbal communication skills. Demonstrated ability to problem solve, innovate and positively influence others. Demonstrated self-management skills, including ability to multi-task. Strong interpersonal, both one-on-one and team based. Proven capacity to understand comprehensive data review principles and demonstrated willingness and ability to quickly learn new technical skills as necessary to the project. Understand the confidential nature of company information and takes necessary steps to ensure its protection.

 

Additional Preferences Knowledge of the clinical trial process. Relational database experience. Capacity to learn and navigate through different data management systems and tools: AS400, Clintrial, Inform, I-Review, Climate, SAS. Awareness and familiarity of statistical methodology.