Clinical Data Cordinator

Key Accountabilities * Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories: Data Review * Performs data review of clinical trial data, including query management * Performs reconciliation review of external data against EDC data * May assist in creating study documents or assist in running study reports and metrics * Performs additional review activities for interim and final database locks as needed. Documentation & Filing * Files study documentation in electronic Trial Master File (eTMF) and department project files. * Performs periodic quality review of eTMF documents. * Assists with taking meeting minutes and documenting/tracking study data management activities. * Performs data archival activities. * Performs inspection readiness activities and supports CDM team during internal and regulatory inspections Data Collection Systems * May support the set-up and testing of study data collection tools. Additional Activities * Assists with quality review of above activities performed by the CRO, as needed. * Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. * Performs other duties as assigned. Educational Qualifications * Associate or Bachelor's Degree preferred Experience * Ideally 1 or more years relevant work experience, or equivalent combination of training and experience. * Familiar with electronic data collection systems * Preferred knowledge of data management best practices & technologies as applied to clinical trials. * Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Special Skills/Abilities * Strong attention to detail, and organizational skills * Good time management skills * Quick learner and comfortable learning new technologies and systems * Good knowledge of office software (Microsoft Office). Behavioral Competencies * Is comfortable with ambiguity. * Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.

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